Study type

Study type

Non-interventional study

Scope of the study

Drug utilisation
Effectiveness study (incl. comparative)
Study drug and medical condition

Name of medicine

ESMYA
Population studied

Age groups

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

Estimated number of subjects

1000
Study design details

Main study objective

The aim of this drug utilization study is to provide real-world data related to the current prescription utilization patterns of Esmya ®.Study objectives are as follows:• To document Esmya ® utilization patterns in real medical practice.• To characterize the patients who are prescribed Esmya ® in real medical practice.• To characterize the profile of prescribers of Esmya.

Data analysis plan

• For the Interim Analysis, the Interim Study Group will include data from Cohort 1 (UK and Germany)• For the Final Analysis, the Final Study Group will include data from two cohorts, the Cohort 1 (UK and Germany) and the Cohort 2 (France, Italy and Spain). The number of patients in the Interim/Final Study Group and their associated characteristics will be described. The number of prescribers and their associated characteristics will also be described.Descriptive statistics will be used to summarize prescriber information and patient medical chart information. Summary statistics for continuous variables will include number of observations, mean, standard deviation, median, minimum, and maximum. Summary statistics for categorical data (dichotomous and polychotomous variables) will include counts and percentages. The 95% confidence intervals (95% CI) will be reported where appropriate. Country-specific analyses will be performed, where appropriate.