Natalizumab

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.
S3778
R8076		 Portaccio (control exposed to IFN), 2018 Major anomalies early pregnancy prospective cohort unexposed, sick Adjustment: No 2.88 [0.25;32.65] C 2/54   1/76 3 54
ref
S3777
R8062		 Portaccio (control unexposed, sick), 2018 Major anomalies early pregnancy prospective cohort unexposed, sick excluded Adjustment: No 4.23 [0.69;25.93] C
excluded (control group) 		2/54   3/333 5 54
ref
S3770
R8058		 Ebrahimi (control unexposed, disease free), 2015 Major birth defects 3 months or more before pregnancy or1st trimester prospective cohort unexposed, disease free excluded Adjustment: No 1.82 [0.30;11.21] C
excluded (control group) 		3/77   2/92 5 77
ref
S3769
R8051		 Ebrahimi (control unexposed, sick), 2015 Major birth defects 3 months or more before pregnancy or1st trimester excluded prospective cohort unexposed, sick Adjustment: No 2.76 [0.28;27.14] C
excluded (exposition period) 		3/77   1/69 4 77
ref
Total 1 studies 2.88 [0.25;32.65] 3 54
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 Portaccio (control exposed to IFN), 2018Portaccio, 2018 1 2.88[0.25; 32.65]3540%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA0.910.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: control exposed to IFN;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 2.88[0.25; 32.65]354 -NAPortaccio (control exposed to IFN), 2018 1 case control studiescase control studies 0 Type of controls unexposed, sickunexposed, sick 2.88[0.25; 32.65]354 -NAPortaccio (control exposed to IFN), 2018 1 Tags Adjustment   - No  - No 2.88[0.25; 32.65]354 -NAPortaccio (control exposed to IFN), 2018 1 All studiesAll studies 2.88[0.25; 32.65]354 -NAPortaccio (control exposed to IFN), 2018 10.510.01.0

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 3770, 3777

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed, sick controlsunexposed, sick controls 3.69[0.86; 15.76]81080%NAPortaccio (control exposed to IFN), 2018 Portaccio (control unexposed, sick), 2018 20.510.01.0