Study type

Study type

Non-interventional study

Scope of the study

Safety study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Intensive monitoring schemes
Study drug and medical condition

Name of medicine

ADAKVEO

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

CRIZANLIZUMAB

Anatomical Therapeutic Chemical (ATC) code

(B06AX01) crizanlizumab
crizanlizumab

Medical condition to be studied

Sickle cell disease
Population studied

Age groups

Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)

Special population of interest

Pregnant women

Estimated number of subjects

500
Study design details

Main study objective

The primary objective is to estimate the proportion of pregnancies resulting in fetal loss (intrauterine death resulting in stillbirth, spontaneous abortion, or induced termination), among pregnant women exposed to crizanlizumab within 105 days prior to LMP or at any time during pregnancy

Outcomes

Fetal loss (intrauterine death resulting in stillbirth, spontaneous abortion, or induced termination), Congenital malformations

Data analysis plan

Data analysis will focus on the prospectively reported pregnancy cases. Descriptive analysis will be performed for prospective pregnancy cases including case disposition and maternal characteristics by providing the number and percentage of pregnancies in each category. Distributions of continuous variables will be summarized with means, standard deviations, medians, and range. Categorical variables will be summarized with proportions. Numbers and proportions (with 95% confidence intervals) for pregnancy outcomes will be reported. Adverse outcomes will be examined by trimester of exposure and concomitant exposure to hydroxyurea/hydroxycarbamide. Case details will be provided separately for retrospective cases.