THE SAVELLA® PREGNANCY REGISTRY (MLN-MD-30 / CMO-EPI-NEU-0539)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Savella

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  350

Study design details

• Main study objective:
  The primary objective is to estimate the prevalence of major congenitalanomalies among offspring of women exposed to Savella duringpregnancy.
• Outcomes:
  To estimate the prevalence of major congenital anomalies among offspring of women exposed to Savella during pregnancy. ; To estimate the prevalence of full-term live births (at least 37 weeks), pre-term live births (<37 weeks), recognized spontaneous abortions, stillbirths, induced abortions (elective and therapeutic), chromosomal abnormalities, and minor congenital anomalies ; To summarize- Serious pregnancy complications and maternal adverse events- Adverse pregnancy outcomes- Serious adverse outcomes
• Data analysis plan:
  The intent of the Registry is to determine whether there is a signal that might indicate a potential risk for major birth defects in the offspring of women following exposure to Savella during pregnancy. ; Therefore, it is necessary to monitor the cumulative data to detect potential signals or patterns, to evaluate them, and to determine the necessary course of action when a signal is noted.

Documents

Study results

CMO-EPI-NEU-0539 CSR Synopsis.pdf