Exposed non-exposed studies (cohort)

Study Country
Study period
Population source Exposure definition Non-exposure definition Sample size Rmk
Gold, 2016 Worldwide
Until 2015
Pregnancy outcomes from adults with relapsing MS who received at least one dose of daclizumab in the phase II SELECT study, phase III DECIDE study [11], and ongoing phase III immunogenicity OBSERVE study, or their respective extension studies. 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.
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.

Case-control studies (cohort)

Study Country
Study period
Case Control Sample size Rmk

master protocol