Fluconazole (all routes except local only) - Cumulative dose ≤ 150 mg updated on 01-29-2025

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.
S17642
R74426		 Molgaard-Nielsen (150 mg), 2013 Any heart defects 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes 1.29 [0.95;1.73] 44/4,082   7,835/968,236 7,879 4,082
ref
S17653
R74572		 Jick (92% received the single 150-mg dose preparation), 1999 Heart defect 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 1.39 [0.16;11.98] C 1/234   5/1,629 6 234
ref
Total 2 studies 1.29 [0.96;1.74] 7,885 4,316
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 Molgaard-Nielsen (150 mg), 2013Molgaard-Nielsen, 2013 1 1.29[0.95; 1.73]7,8794,08298%ROB confusion: seriousROB selection: lowROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Jick (92% received the single 150-mg dose preparation), 1999Jick, 1999 2 1.39[0.16; 11.98]62342%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: unclearROB mesure: criticalROB reporting: moderate Total (2 studies) I2 = 0% 1.29[0.96; 1.74]7,8854,3160.55.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: 150 mg; 2: 92% received the single 150-mg dose preparation;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.29[0.96; 1.74]7,8854,3160%NAMolgaard-Nielsen (150 mg), 2013 Jick (92% received the single 150-mg dose preparation), 1999 2 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.29[0.96; 1.74]7,8854,3160%NAMolgaard-Nielsen (150 mg), 2013 Jick (92% received the single 150-mg dose preparation), 1999 2 Tags Adjustment   - No  - No 1.39[0.16; 11.98]6234 -NAJick (92% received the single 150-mg dose preparation), 1999 1   - Yes  - Yes 1.29[0.96; 1.74]7,8794,082 -NAMolgaard-Nielsen (150 mg), 2013 1 All studiesAll studies 1.29[0.96; 1.74]7,8854,3160%NAMolgaard-Nielsen (150 mg), 2013 Jick (92% received the single 150-mg dose preparation), 1999 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

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.29[0.96; 1.74]7,8854,3160%NAMolgaard-Nielsen (150 mg), 2013 Jick (92% received the single 150-mg dose preparation), 1999 20.510.01.0