Fingolimod

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.
S4889
R12887		 Pauliat, 2020 Major congenital anomalies (excluding genetic and chromosomic disorders) 1st trimester prospective cohort exposed to other treatment, sick Adjustment: No Matched 2.20 [0.20;24.60] 2/42   1/44 3 42
ref
S3803
R8118		 Karlsson (control exposed to IFN), 2014 Major malformations 1st trimester retrospective cohort exposed to other treatment, sick excluded Adjustment: No 0.37 [0.01;10.90] C
excluded (control group) 		3/32   0/2 3 32
ref
S3802
R8115		 Karlsson (control unexposed, sick), 2014 Major malformations 1st trimester retrospective cohort unexposed, sick Adjustment: No 0.12 [0.00;7.22] C 3/32   0/1 3 32
ref
Total 2 studies 0.85 [0.06;12.12] 6 74
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 Pauliat, 2020Pauliat, 2020 2.20[0.20; 24.60]34267%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Karlsson (control unexposed, sick), 2014Karlsson, 2014 1 0.12[0.00; 7.22]33233%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (2 studies) I2 = 30% 0.85[0.06; 12.12]6740.05.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: control unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 0.85[0.06; 12.12]67430%NAPauliat, 2020 Karlsson (control unexposed, sick), 2014 2 case control studiescase control studies 0 Type of controls unexposed, sickunexposed, sick 0.12[0.00; 7.22]332 -NAKarlsson (control unexposed, sick), 2014 1 exposed to other treatment, sickexposed to other treatment, sick 2.20[0.20; 24.40]342 -NAPauliat, 2020 1 Tags Adjustment   - No  - No 0.85[0.06; 12.12]67430%NAPauliat, 2020 Karlsson (control unexposed, sick), 2014 2 MatchedMatched 2.20[0.20; 24.40]342 -NAPauliat, 2020 1 All studiesAll studies 0.85[0.06; 12.12]67430%NAPauliat, 2020 Karlsson (control unexposed, sick), 2014 20.05.01.0

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 3803

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed, sick controlsunexposed, sick controls Out of scale0.12[0.00; 7.22]332 -NAKarlsson (control unexposed, sick), 2014 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.21[0.17; 8.59]6740%NAPauliat, 2020 Karlsson (control exposed to IFN), 2014 20.510.01.0