Daclizumab

Exposed non-exposed, cohort studies

Study Country
Study period
Study design
Data source Exposure definition Non-exposure definition Exposition period Sample size
(exposed/unexposed) Or (case / control)
Remarks Risk of bias
Gold
2016
Worldwide
Until 2015
retrospective cohort
Daclizumab clinical study program. MS women who became pregnant while receiving daclizumab or <=6 months after the final dose unexposed, sick
MS women who have stopped daclizumab at least 6 months before becoming pregnant.
3 months or more before pregnancy or1st trimester 38 / 6 Half-life: 21 days (7*21 days = 147 days : about 5 months). In the event of pregnancy, daclizumab was discontinued and safety monitoring continued.
Clinics visits occurred every 4 weeks for daclizumab administration and safety and tolerability assessments; during the extension studies, visits were every 4–12 weeks.

Case-control studies

Study Country
Study period
Study design
Data source Case Control Exposition Exposition period Sample size
(exposed/unexposed) Or (case / control)
Remarks Risk of bias

Risk of bias: : NA;   : low;   : moderate;   : serious;   : critical;   : unclear;  

Empty. There are no case-control studies available for this drug.

master protocol