Itraconazole updated on 01-29-2025

Major congenital malformations

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.
S17549
R73907		 Molgaard-Nielsen, 2013 Major birth defects 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes 1.25 [0.82;1.92] 22/687   25,159/968,236 25,181 687
ref
S17548
R73901		 De Santis, 2009 Major congenital anomalies 1st trimester prospective cohort unexposed (general population or NOS) Adjustment: No Matched 0.87 [0.19;3.95] C 3/163   4/190 7 163
ref
S17547
R73888		 Bar-Oz, 2000 Major birth defects 1st trimester prospective cohort unexposed (general population or NOS) Adjustment: No Matched 0.67 [0.23;1.95] 5/156   9/187 14 156
ref
S17527
R73749		 Jick, 1999 Congenital anomaly 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 2.18 [0.65;7.33] C 3/88   26/1,629 29 88
ref
Total 4 studies 1.20 [0.83;1.72] 25,231 1,094
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, 2013Molgaard-Nielsen, 2013 1.25[0.82; 1.92]25,18168774%ROB confusion: seriousROB selection: lowROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate De Santis, 2009De Santis, 2009 0.87[0.19; 3.95]71636%ROB confusion: criticalROB selection: criticalROB classification: moderateROB missing: unclearROB mesure: criticalROB reporting: moderate Bar-Oz, 2000Bar-Oz, 2000 0.67[0.23; 1.95]1415612%ROB confusion: criticalROB selection: criticalROB classification: moderateROB missing: criticalROB mesure: criticalROB reporting: moderate Jick, 1999Jick, 1999 2.18[0.65; 7.33]29889%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: unclearROB mesure: criticalROB reporting: moderate Total (4 studies) I2 = 0% 1.20[0.83; 1.72]25,2311,0940.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.20[0.83; 1.72]25,2311,0940%NAMolgaard-Nielsen, 2013 De Santis, 2009 Bar-Oz, 2000 Jick, 1999 4 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.20[0.83; 1.72]25,2311,0940%NAMolgaard-Nielsen, 2013 De Santis, 2009 Bar-Oz, 2000 Jick, 1999 4 Tags Adjustment   - No  - No 1.06[0.51; 2.21]504076%NADe Santis, 2009 Bar-Oz, 2000 Jick, 1999 3   - Yes  - Yes 1.25[0.82; 1.91]25,181687 -NAMolgaard-Nielsen, 2013 1 MatchedMatched 0.73[0.31; 1.75]213190%NADe Santis, 2009 Bar-Oz, 2000 2 All studiesAll studies 1.20[0.83; 1.72]25,2311,0940%NAMolgaard-Nielsen, 2013 De Santis, 2009 Bar-Oz, 2000 Jick, 1999 40.25.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-1.82.00.9260.000Molgaard-Nielsen, 2013De Santis, 2009Bar-Oz, 2000Jick, 1999

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

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.20[0.83; 1.72]25,2311,0940%NAMolgaard-Nielsen, 2013 De Santis, 2009 Bar-Oz, 2000 Jick, 1999 40.510.01.0