Oxcarbazepine (All indications)

Preterm (< 37 weeks)

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.
S9039
R30838		 Aydin (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2020 Preterm delivery (before 37 weeks of gestation) throughout pregnancy retrospective cohort exposed to other treatment, sick excluded Adjustment: No 1.86 [0.03;115.45] C
excluded (control group) 		0/4   0/7 0 4
ref
S9040
R30848		 Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020 Preterm delivery (before 37 weeks of gestation) throughout pregnancy retrospective cohort unexposed, sick Adjustment: No 1.11 [0.04;28.53] C 0/4   2/22 2 4
ref
S10097
R36764		 Coste (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2020 Gestational age at birth (< 37 WA) during pregnancy (anytime or not specified) retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No Controls: mixed indications 1.13 [0.58;2.19] C
excluded (control group) 		10/143   182/2,916 192 143
ref
S9087
R31110		 Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 Gestational age at birth (< 37 WA) during pregnancy (anytime or not specified) retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 1.33 [0.70;2.54] C 10/143   91,255/1,710,441 91,265 143
ref
S9041
R30862		 Cohen (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 Preterm birth (ICD-9 644.2, 774.2, 776.6, 362.20, 362.22, 362.27, 765 excluding 765.20, 765.29) early pregnancy retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: Yes 1.28 [1.06;1.55]
excluded (control group) 		187/1,109   392/2,682 579 1,109
ref
S9043
R30876		 Cohen (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 Preterm birth (ICD-9 644.2, 774.2, 776.6, 362.20, 362.22, 362.27, 765 excluding 765.20, 765.29) early pregnancy retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: Yes 1.09 [0.95;1.25] 187/1,109   160,604/1,440,631 160,791 1,109
ref
S9042
R30865		 Bank (Oxcarbazepine) (Mixed indications), 2017 Premature (<37 weeks gestation) during pregnancy (anytime or not specified) prospective cohort exposed to other treatment, sick Adjustment: No 3.29 [0.11;96.92] C 0/4   1/36 1 4
ref
S9093
R31153		 Kilic (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Preterm (< 37 weeks) during pregnancy (anytime or not specified) population based cohort retrospective exposed to other treatment, sick excluded Adjustment: No 0.66 [0.40;1.10] C
excluded (control group) 		20/310   83/880 103 310
ref
S9094
R31156		 Kilic (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2014 Preterm (< 37 weeks) during pregnancy (anytime or not specified) population based cohort retrospective unexposed (general population or NOS) excluded Adjustment: No 1.30 [0.80;2.00]
excluded (control group) 		20/310   33,974/676,834 33,994 310
ref
S9095
R31159		 Kilic (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014 Preterm (< 37 weeks) during pregnancy (anytime or not specified) population based cohort retrospective unexposed, sick Adjustment: No Controls: epilepsy indication 0.88 [0.56;1.41] C 20/310   383/5,296 403 310
ref
S9036
R30809		 Artama (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2013 Preterm birth (<37 gestational weeks) during pregnancy (anytime or not specified) population based cohort retrospective exposed to other treatment, sick excluded Adjustment: No 0.94 [0.41;2.14] C
excluded (control group) 		23/527   8/173 31 527
ref
S9037
R30821		 Artama (Oxcarbazepine) (Controls unexposed, disease free), 2013 Preterm birth (<37 gestational weeks) during pregnancy (anytime or not specified) population based cohort retrospective unexposed, disease free excluded Adjustment: Yes 1.00 [0.66;1.52]
excluded (control group) 		23/527   30,027/719,509 30,050 527
ref
S9038
R30833		 Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 Preterm birth (<37 gestational weeks) during pregnancy (anytime or not specified) population based cohort retrospective unexposed, sick Adjustment: Yes 0.89 [0.55;1.44] 23/527   85/1,793 108 527
ref
Total 6 studies 1.07 [0.94;1.21] 252,570 2,097
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 Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020Aydin, 2020 1 1.11[0.04; 28.53]240%ROB confusion: criticalROB selection: criticalROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020Coste, 2020 2 1.33[0.70; 2.54]91,2651434%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Cohen (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019Cohen, 2019 3 1.09[0.95; 1.25]160,7911,10982%ROB confusion: moderateROB selection: lowROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate Bank (Oxcarbazepine) (Mixed indications), 2017Bank, 2017 4 3.29[0.11; 96.92]140%ROB confusion: criticalROB selection: lowROB classification: lowROB missing: lowROB mesure: moderateROB reporting: moderate Kilic (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014Kilic, 2014 5 0.88[0.56; 1.41]4033107%ROB confusion: criticalROB selection: lowROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Artama (Oxcarbazepine) (Controls unexposed, sick), 2013Artama, 2013 6 0.89[0.55; 1.44]1085277%ROB confusion: moderateROB selection: lowROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Total (6 studies) I2 = 0% 1.07[0.94; 1.21]252,5702,0970.210.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Oxcarbazepine) (Controls unexposed, sick; 2: Oxcarbazepine) (Controls unexposed, NOS; 3: Oxcarbazepine) (Controls unexposed NOS) (Mixed indications; 4: Oxcarbazepine) (Mixed indications; 5: Oxcarbazepine) (Controls unexposed, sick) (Mixed indications; 6: Oxcarbazepine) (Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.07[0.94; 1.21]252,5702,0970%NAAydin (Oxcarbazepine) (Controls unexposed, sick), 2020 Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 Cohen (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 Bank (Oxcarbazepine) (Mixed indications), 2017 Kilic (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014 Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 6 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.10[0.96; 1.26]252,0561,2520%NACoste (Oxcarbazepine) (Controls unexposed, NOS), 2020 Cohen (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 2 unexposed, sickunexposed, sick 0.89[0.64; 1.24]5138410%NAAydin (Oxcarbazepine) (Controls unexposed, sick), 2020 Kilic (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014 Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 3 exposed to other treatment, sickexposed to other treatment, sick 3.29[0.11; 96.92]14 -NABank (Oxcarbazepine) (Mixed indications), 2017 1 Tags Adjustment   - No  - No 1.03[0.71; 1.50]91,6714610%NAAydin (Oxcarbazepine) (Controls unexposed, sick), 2020 Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 Bank (Oxcarbazepine) (Mixed indications), 2017 Kilic (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014 4   - Yes  - Yes 1.07[0.94; 1.22]160,8991,6360%NACohen (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 2 Controls   - epilepsy indication  - epilepsy indication 0.88[0.56; 1.41]403310 -NAKilic (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014 1 All studiesAll studies 1.07[0.94; 1.21]252,5702,0970%NAAydin (Oxcarbazepine) (Controls unexposed, sick), 2020 Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 Cohen (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 Bank (Oxcarbazepine) (Mixed indications), 2017 Kilic (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014 Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 60.210.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-4.14.12.0720.000Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020Cohen (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019Bank (Oxcarbazepine) (Mixed indications), 2017Kilic (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014Artama (Oxcarbazepine) (Controls unexposed, sick), 2013

Asymetry test p-value = 0.9521 (by Egger's regression)

slope=0.0639 (0.0646); intercept=0.0266 (0.4158); t=0.0640; p=0.9521

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 9036, 9037, 9093, 9094, 9041, 9039, 10097

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.10[0.98; 1.25]316,1002,0890%NACoste (Oxcarbazepine) (Controls unexposed, NOS), 2020 Cohen (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 Kilic (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2014 Artama (Oxcarbazepine) (Controls unexposed, disease free), 2013 4 unexposed, sick controlsunexposed, sick controls 0.89[0.64; 1.24]5138410%NAAydin (Oxcarbazepine) (Controls unexposed, sick), 2020 Kilic (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014 Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 3 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.07[0.81; 1.41]9062,09722%NAAydin (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2020 Coste (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2020 Cohen (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 Bank (Oxcarbazepine) (Mixed indications), 2017 Kilic (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Artama (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2013 60.510.01.0