Natalizumab

All congenital malformations (majors, minors, majors and minors, or unspecified)

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
R8078
Portaccio (control exposed to IFN), 2018 Malformations (minor and major) early pregnancy prospective cohort unexposed, sick Adjustment: No 5.51 [1.10;27.66] C 7/54   2/76 9 54
ref
S3777
R8064
Portaccio (control unexposed, sick), 2018 Malformations (minor and major) early pregnancy prospective cohort unexposed, sick excluded Adjustment: No 8.12 [2.62;25.19] C
excluded (control group)
7/54   6/333 13 54
ref
S3770
R8057
Ebrahimi (control unexposed, disease free), 2015 All anomalies 3 months or more before pregnancy or1st trimester prospective cohort unexposed, disease free excluded Adjustment: No 0.95 [0.25;3.68] C
excluded (control group)
4/77   5/92 9 77
ref
S3769
R8050
Ebrahimi (control unexposed, sick), 2015 All anomalies 3 months or more before pregnancy or1st trimester excluded prospective cohort unexposed, sick Adjustment: No 1.21 [0.26;5.59] C
excluded (exposition period)
4/77   3/69 7 77
ref
Total 1 studies 5.51 [1.10;27.66] 9 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 5.51[1.10; 27.66]9540%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA0.920.01.0ROB: 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 5.51[1.10; 27.66]954 -NAPortaccio (control exposed to IFN), 2018 1 case control studiescase control studies 0 Type of controls unexposed, sickunexposed, sick 5.51[1.10; 27.66]954 -NAPortaccio (control exposed to IFN), 2018 1 Tags Adjustment   - No  - No 5.51[1.10; 27.66]954 -NAPortaccio (control exposed to IFN), 2018 1 All studiesAll studies 5.51[1.10; 27.66]954 -NAPortaccio (control exposed to IFN), 2018 10.520.01.0

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 7.14[2.83; 18.05]221080%NAPortaccio (control exposed to IFN), 2018 Portaccio (control unexposed, sick), 2018 20.510.01.0