Daclizumab

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.

Study	Country Study period	Case	Control	Sample size	Rmk