Olanzapine updated on 06-10-2025

Congenital heart defects

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.
S18397
R77603		 Chan (Controls exposed to FGA), 2024 Cardiac malformations at least 1st trimester retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No 1.44 [0.38;5.54] C
excluded (control group) 		3/110   8/420 11 110
ref
S18340
R77375		 Chan (Controls unexposed, general pop), 2024 Cardiac malformations at least 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) excluded Adjustment: Yes 1.56 [0.29;7.86]
excluded (control group) 		3/110   8,218/464,017 8,221 110
ref
S18394
R77593		 Chan (Controls unexposed, sick), 2024 Cardiac malformations at least 1st trimester retrospective cohort (claims database) unexposed, sick Adjustment: Yes 1.28 [0.12;24.29] 2/101   135/6,476 137 101
ref
S14305
R56417		 Huybrechts (Controls unexposed, NOS), 2023 Cardiovascular Malformations 1st trimester population based cohort retrospective unexposed (general population or NOS) excluded Adjustment: Yes 1.22 [0.91;1.63]
excluded (control group) 		-/3,110   -/6,455,324 - 3,110
ref
S14304
R56405		 Huybrechts (Controls unexposed, sick), 2023 Cardiovascular Malformations 1st trimester population based cohort retrospective unexposed, sick Adjustment: Yes 1.09 [0.78;1.52] -/2,341   -/318,731 - 2,341
ref
Total 2 studies 1.09 [0.78;1.52] 137 2,442
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 Chan (Controls unexposed, sick), 2024Chan, 2024 1 1.28[0.12; 24.29]1371012%ROB confusion: seriousROB selection: moderateROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate Huybrechts (Controls unexposed, sick), 2023Huybrechts, 2023 2 1.09[0.78; 1.52]-2,34198%ROB confusion: moderateROB selection: moderateROB classification: moderateROB missing: unclearROB mesure: unclearROB reporting: moderate Total (2 studies) I2 = 0% 1.09[0.78; 1.52]1372,4420.55.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, sick; 2: Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.09[0.78; 1.52]1372,4420%NAChan (Controls unexposed, sick), 2024 Huybrechts (Controls unexposed, sick), 2023 2 case control studiescase control studies 0 Type of controls unexposed, sickunexposed, sick 1.09[0.78; 1.52]1372,4420%NAChan (Controls unexposed, sick), 2024 Huybrechts (Controls unexposed, sick), 2023 2 Tags Adjustment   - Yes  - Yes 1.09[0.78; 1.52]1372,4420%NAChan (Controls unexposed, sick), 2024 Huybrechts (Controls unexposed, sick), 2023 2 All studiesAll studies 1.09[0.78; 1.52]1372,4420%NAChan (Controls unexposed, sick), 2024 Huybrechts (Controls unexposed, sick), 2023 20.55.01.0

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 14305, 18397, 18340

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.23[0.92; 1.64]8,2213,2200%NAChan (Controls unexposed, general pop), 2024 Huybrechts (Controls unexposed, NOS), 2023 2 unexposed, sick controlsunexposed, sick controls 1.09[0.78; 1.52]1372,4420%NAChan (Controls unexposed, sick), 2024 Huybrechts (Controls unexposed, sick), 2023 2 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.44[0.38; 5.54]11110 -NAChan (Controls exposed to FGA), 2024 10.510.01.0