Study type

Study type

Not applicable

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

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

Anatomical Therapeutic Chemical (ATC) code

(L04AX04) lenalidomide
lenalidomide

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 perform a cumulative root-cause analysis for all pregnancies which have occurred in association with an exposition to a lenalidomide product of the STADA group included in the concerned procedures (IS/H/0275/001-007/DC, IS/H/0376/001-007/DC, IS/H/0377/001-007/DC) and to identify causes that could indicate a failure or weakness of the PPP.

Outcomes

Pregnancy in female patient: conception up to 4 weeks after lenalidomide exposition in female patient // Pregnancy in female partner of male patient: conception up to 7 days after lenalidomide exposition in male patient

Data analysis plan

Data analysis is performed as follows: (i) Cumulative case analysis of all pregnancy cases in association with an exposition to a lenalidomide product of the STADA group included in the concerned procedures, (ii) Descriptive statistics for summarizing data from pregnancy cases in association with an exposition to a lenalidomide product of the STADA group included in the concerned procedures