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. |
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;