AMEVIVE® Pregnancy Registry
AMEVIVE® Pregnancy Registry
This is an observational, exposure-registration and follow-up study, to be conducted in the
 United States (US). The AMEVIVE® Pregnancy Exposure Registry is designed to monitor pregnant
 subjects and fetuses exposed to AMEVIVE® in order to detect any potential increase in the
 risk of major birth defects.

 The AMEVIVE® Pregnancy Exposure Registry is sponsored by Astellas Pharma Global Development
 and will be managed by INC Research. The Registry will be monitored by an independent
 Advisory Committee of external experts in relevant specialties of teratology, epidemiology,
 maternal and fetal medicine, and infectious disease medicine (external member details
 available upon request).
Prospective reports will be collected from pregnant subjects, health care provider (HCP), or
 Astellas Product Safety Management staff. Data from the pregnant subjects will be collected
 at 4 to 5 months of pregnancy by telephone interviews with the Registry. The Registry will
 also contact the subject at 2 months and 12 months after the estimated delivery date (EDD)
 for post-natal & pediatric follow-up. The Registry will confirm the information collected
 from the subject with the HCP by telephone interviews with the Registry, forms mailed/faxed
 to the Registry, electronic forms/queries sent to the Registry, or a combination of these
 methods. If a live birth is reported, the infant's HCP will be contacted for the Pediatric
 Follow-Up at 2 months and 12 months of age. If a birth defect is reported, targeted follow-up
 will be conducted.
Inclusion Criteria:

 -  Have been exposed to AMEVIVE® within 8 weeks prior to conception or at any time during
 pregnancy

 -  Provide sufficient information to determine that the pregnancy is prospectively
 registered (i.e., the outcome of pregnancy must be unknown prospectively)

 -  Provide verbal consent to participate in the Registry, and

 -  Verbally provide the contact information for herself, her healthcare provider (HCP),
 and the infant's HCP (if applicable)

 Exclusion Criteria:

 -  None