Natalizumab

Minor 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
R8077
Portaccio (control exposed to IFN), 2018 Minor malformations early pregnancy prospective cohort unexposed, sick Adjustment: No 7.65 [0.87;67.50] C 5/54   1/76 6 54
ref
S3777
R8063
Portaccio (control unexposed, sick), 2018 Minor malformations early pregnancy prospective cohort unexposed, sick excluded Adjustment: No 11.22 [2.60;48.45] C
excluded (control group)
5/54   3/333 8 54
ref
Total 1 studies 7.65 [0.87;67.50] 6 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 7.65[0.87; 67.50]6540%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 7.65[0.87; 67.50]654 -NAPortaccio (control exposed to IFN), 2018 1 case control studiescase control studies 0 Type of controls unexposed, sickunexposed, sick 7.65[0.87; 67.50]654 -NAPortaccio (control exposed to IFN), 2018 1 Tags Adjustment   - No  - No 7.65[0.87; 67.50]654 -NAPortaccio (control exposed to IFN), 2018 1 All studiesAll studies 7.65[0.87; 67.50]654 -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 3777

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed, sick controlsunexposed, sick controls 9.96[2.96; 33.55]141080%NAPortaccio (control exposed to IFN), 2018 Portaccio (control unexposed, sick), 2018 20.510.01.0