Postmarketing non-interventional safety study on medicinal products containing aromatase inhibitors, Anastrozol Actavis 1 mg, Exemestan Actavis 25 mg, Trozara 2,5 mg

02/11/2015
02/11/2015
EU PAS number:
EUPAS11481
Study
Planned
Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Other

If ‘other’, further details on the scope of the study

Patient´s and treatment characteristics
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(L02BG) Aromatase inhibitors
Aromatase inhibitors
Population studied

Age groups

  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)

Estimated number of subjects

450
Study design details

Main study objective

Obtaining information about safety of the drug and patient´s characterstics.

Data analysis plan

Query investigation with statistical evaluation of results.