Study type

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

Study drug International non-proprietary name (INN) or common name

VENLAFAXINE
Population studied

Age groups

  • Paediatric Population (< 18 years)
    • Neonate
      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)

Special population of interest

Pregnant women

Estimated number of subjects

1300
Study design details

Main study objective

To assess the risk of venlafaxine exposure in early pregancy

Outcomes

Rate of major birth defects after first trimester exposure, rate of spontaneous abortionrate of prematuritybirth weightpostnatal disorders

Data analysis plan

Birth defect rates include live births and anomalies in elective terminations of pregnancies (ETOPs) and miscarriages. For calculating rates of major birth defects possibly associated with a teratogen, welldefined genetic syndromes are excluded. See: Schaefer C, Ornoy A, Clementi M, Meister R, Weber-Schoendorfer C. Using observational cohort data for studying drug effects on pregnancy outcome--methodological considerations. Reprod Toxicol. 2008,26:36-41. For calculation spontaneous abortion rate see Meister R, Schaefer C. Statistical methods for estimating the probability of spontaneous abortion in observational studies--analyzing pregnancies exposed to coumarin derivatives. Reprod Toxicol. 2008,26:31-5