Since Idiopathic Thrombocytopenic Purpura (ITP) affects women who are of reproductive
capacity and taking into account the lack of data concerning Eltrombopag (Promacta) use
during pregnancy, the Eltrombopag (Promacta) Registry will be an essential component of the
ongoing risk management for Eltrombopag (Promacta). The Registry will detect and record the
events (live births, spontaneous abortions, stillbirths, elective terminations, therapeutic
terminations, any serious pregnancy outcome, major and minor congenital anomalies, outcomes
including preterm, small for gestation age, or intrauterine growth restriction adverse
adverse effects on the following: immune system development, platelet number and function,
neoplasm formation, bone marrow reticulin formation, thrombotic events) in the mother and/or
the neonate/infant. The adverse events in the infant will be assessed through at least the
first year of life. The Pregnancy Registry will compare the pregnancy and fetal outcomes of
women exposed to eltrombopag Tablets during pregnancy to an unexposed control population.
This study will be a prospective observational, exposure follow-up study.