Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05690 (Care Program) (P05710)

Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate)

Time frame · From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)

The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05690 with at least one live born infant during follow up relative to the number of participants treated in base study.

Number of Expectant Mothers Experiencing Adverse Events (AEs)

Time frame · From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Number of Expectant Mothers Experiencing Serious AEs (SAEs)

Time frame · From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)

An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.

Number of Infants Experiencing AEs

Time frame · Up to 12 weeks after birth

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Number of Infants Experiencing SAEs

Time frame · Up to 12 weeks after birth

An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.