Oxcarbazepine (All indications)

Oro-facial clefts

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.
S10171
R46497
Blotière (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 Oro-facial clefts 1st trimester retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No 2.40 [0.13;44.81] C
excluded (control group)
0/139   4/2,997 4 139
ref
S10039
R46488
Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 Oro-facial clefts 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 2.40 [0.15;38.60] C 0/139   2,815/1,875,733 2,815 139
ref
S9074
R31063
Tomson (Oxcarbazepine), 2018 Cleft lip or palate at least 1st trimester prospective cohort exposed to other treatment, sick Adjustment: No 2.52 [0.26;24.31] C 1/333   3/2,514 4 333
ref
S9052
R30896
Veiby (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Orofacial clefts throughout pregnancy population based cohort retrospective exposed to other treatment, sick Adjustment: No 4.91 [0.20;121.80] C 0/57   1/833 1 57
ref
S9062
R30935
Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 Facial cleft 1st trimester prospective cohort exposed to other treatment, sick Adjustment: No 33.10 [1.23;890.88] C 0/7   1/647 1 7
ref
Total 4 studies 4.48 [1.11;18.10] 2,821 536
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 (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019Blotière, 2019 1 2.40[0.15; 38.60]2,81513925%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Tomson (Oxcarbazepine), 2018Tomson, 2018 2 2.52[0.26; 24.31]433338%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Veiby (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014Veiby, 2014 3 4.91[0.20; 121.80]15719%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: moderateROB reporting: moderate Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006Morrow, 2006 4 33.10[1.23; 890.88]1718%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (4 studies) I2 = 0% 4.48[1.11; 18.10]2,8215360.9100.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Oxcarbazepine) (Controls unexposed NOS) (Mixed indications; 2: Oxcarbazepine; 3: Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications; 4: Oxcarbazepine) (Controls exposed to Lamotrigine, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 4.48[1.11; 18.10]2,8215360%NABlotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 Tomson (Oxcarbazepine), 2018 Veiby (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 4 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 2.40[0.15; 38.60]2,815139 -NABlotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 1 exposed to other treatment, sickexposed to other treatment, sick 5.54[1.10; 27.81]63970%NATomson (Oxcarbazepine), 2018 Veiby (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 3 Tags Adjustment   - No  - No 4.48[1.11; 18.10]2,8215360%NABlotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 Tomson (Oxcarbazepine), 2018 Veiby (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 4 All studiesAll studies 4.48[1.11; 18.10]2,8215360%NABlotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 Tomson (Oxcarbazepine), 2018 Veiby (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 40.5100.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-4.25.52.0160.000Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019Tomson (Oxcarbazepine), 2018Veiby (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006

Asymetry test p-value = NaN (by Egger's regression)

not enought points

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 10171

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 2.40[0.15; 38.60]2,815139 -NABlotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 4.56[1.11; 18.73]105360%NABlotière (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 Tomson (Oxcarbazepine), 2018 Veiby (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 40.510.01.0