Oxcarbazepine (All indications)

Spina bifida

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
R37132
Blotière (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 Spina bifida 1st trimester retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No 7.21 [0.29;177.79] C
excluded (control group)
0/139   1/2,997 1 139
ref
S10039
R36240
Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 Spina bifida 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 10.98 [0.68;176.63] C 0/139   616/1,875,733 616 139
ref
S9052
R30895
Veiby (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Spina bifida throughout pregnancy population based cohort retrospective exposed to other treatment, sick excluded Adjustment: No 14.73 [0.29;749.53] C
excluded (control group)
0/57   0/833 0 57
ref
S9054
R30902
Veiby (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014 Spina bifida throughout pregnancy population based cohort retrospective unexposed, sick Adjustment: No Controls: epilepsy indication 9.53 [0.49;186.68] C 0/57   3/3,773 3 57
ref
S9065
R30945
Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006 Spina bifida throughout pregnancy prospective cohort unexposed, sick Adjustment: No 34.33 [0.49;2389.88] C 0/2   0/52 0 2
ref
S9057
R30912
Artama (Oxcarbazepine), 2005 Spina bifida 1st trimester retrospective cohort (registry) unexposed, sick Adjustment: No 9.53 [0.19;482.86] C 0/99   0/939 0 99
ref
Total 4 studies 12.20 [2.32;64.13] 619 297
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 10.98[0.68; 176.63]61613936%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Veiby (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014Veiby, 2014 2 9.53[0.49; 186.68]35731%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: moderateROB reporting: moderate Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006Viinikainen, 2006 3 34.33[0.49; 2389.88]0215%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate Artama (Oxcarbazepine), 2005Artama, 2005 4 9.53[0.19; 482.86]09918%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (4 studies) I2 = 0% 12.20[2.32; 64.13]6192970.9100.01.0ROB: 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) (Controls unexposed, sick) (Mixed indications; 3: Oxcarbazepine) (Controls unexposed, sick) ; 4: Oxcarbazepine;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 12.20[2.32; 64.13]6192970%NABlotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 Veiby (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014 Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006 Artama (Oxcarbazepine), 2005 4 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 10.98[0.68; 176.63]616139 -NABlotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 1 unexposed, sickunexposed, sick 12.93[1.63; 102.43]31580%NAVeiby (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014 Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006 Artama (Oxcarbazepine), 2005 3 Tags Adjustment   - No  - No 12.20[2.32; 64.13]6192970%NABlotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 Veiby (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014 Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006 Artama (Oxcarbazepine), 2005 4 Controls   - epilepsy indication  - epilepsy indication 9.53[0.49; 186.68]357 -NAVeiby (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014 1 All studiesAll studies 12.20[2.32; 64.13]6192970%NABlotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 Veiby (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014 Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006 Artama (Oxcarbazepine), 2005 40.5100.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-5.17.62.5980.000Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019Veiby (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006Artama (Oxcarbazepine), 2005

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 9052, 10171

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) Out of scale10.98[0.68; 176.63]616139 -NABlotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 1 unexposed, sick controlsunexposed, sick controls Out of scale12.93[1.63; 102.43]31580%NAVeiby (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014 Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006 Artama (Oxcarbazepine), 2005 3 exposed to other treatment, sick controlsexposed to other treatment, sick controls 9.59[0.80; 114.97]11960%NABlotière (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 Veiby (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 20.510.01.0