Primary Outcome Measures:
- Number of spontaneous abortions, fetal losses including stillbirths, and ectopic pregnancies [ Time Frame: Approximately 9 months ]
- Number of elective or therapeutic pregnancy terminations [ Time Frame: Approximately 9 months ]
- Number of Live Births [ Time Frame: 4 weeks after the estimated date of delivery ]
- Number of Live Births with Birth Defects [ Time Frame: 8-12 weeks post-birth ]
This study was conducted in coordination with the TYSABRI® Global Observational Program in Safety (TYGRIS) observational study in the United States (US), Canada, and Rest of World (ROW).
The Coordinating Center (CC) monitored participants throughout their pregnancies and monitored the infants until 8 to 12 weeks of age in the US and Canada, and within 4 weeks after the Estimated Date of Delivery (EDD) in the ROW.