The Gilenya Pregnancy Registry | NCT01285479 | Trialant

The Gilenya Pregnancy Registry | NCT01285479 | Trialant

Arms/Interventions Module

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of major malformations associated with exposure to fingolimod during pregnancy	Major malformations are defined as any structural defect with surgical, medical, or cosmetic importance recognized.	Up to 23 months
Frequency of minor congenital malformations associated to fingolimod during pregnancy	Minor congenital malformations: Minor anomalies, i.e., anomalies with no serious medical or cosmetic consequence to the child. Positional deformities, i.e., a positional deformity that usually normalizes spontaneously after about 3 months of age, e.g., abnormal head shape, torticollis. Features of pre-maturity. Chromosome abnormalities. Genetic disorders.	Up to 23 months

Secondary Outcomes

Measure	Description	Time Frame
Frequency of specific types of major and minor congenital malformations associated with exposure to fingolimod during pregnancy	Frequency of specific types of major and minor congenital malformations associated with exposure to fingolimod during pregnancy would be collected	Up to 23 months
Number of spontaneous abortions, stillbirths and elective terminations;

Contacts/Locations Module

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases