Study type

Study type

Not applicable

If ‘Not applicable’, further details on the study type

Root-cause analysis of spontaneously reported pregnancy cases and systematic database review
Study drug and medical condition

Medicinal product name, other

Lenalidomid AL 2,5 / 5 / 7,5 / 10 / 15 / 20 / 25 mg Hartkapseln, Lenalidomid STADA 2,5 / 5 / 7,5 / 10 / 15 / 20 / 25 mg Hartkapseln

Medical condition to be studied

Exposure during pregnancy
Population studied

Age groups

  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)

Special population of interest

Pregnant women

Estimated number of subjects

0
Study design details

Main study objective

The objectives of this study are to identify and follow-up on all pregnancies which occur in association with an exposition to Lenalidomid AL Hartkapseln or Lenalidomid STADA Hartkapseln in Germany, to perform a root-cause analysis for such identified cases, and to identify causes that could indicate a failure or weakness of the PPP.

Outcomes

(i) Pregnancy in female patient: conception up to 4 weeks after lenalidomide exposition in female patient, (ii) Pregnancy in female partner of male patient: conception up to 7 days after lenalidomide exposition in male patient.

Data analysis plan

Data analysis will be performed as follows: (i) Single case analysis of all pregnancy cases in association with an exposition to Lenalidomid AL Hartkapseln or Lenalidomid STADA Hartkapseln in Germany reported to or identified by STADA, (ii) Descriptive statistics for summarizing data from pregnancy cases in association with an exposition to Lenalidomid AL Hartkapseln or Lenalidomid STADA Hartkapseln.