Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT01607333
Eligibility Criteria:
Inclusion Criteria for the descriptive studies to compare the six European databases:
* patients with at least one prescription to an AED between January 1, 2000 and December 31, 2009
* patients who fulfill the quality criteria of the respective database
Inclusion Criteria for the additional descriptive studies comparing the study populations from GPRD and Danish data sources and cohort study:
* patients who have received a first prescription to at least one AED at July 1, 1996 or later in the UK or Denmark
* patients who are an age of 15 years and older at the index date
* patients who have a registration history of at least 6 months prior to the index date (first date of AED prescription)
* patients who have fulfilled research data criteria in GPRD
Exclusion Criteria for the descriptive studies to compare the six European databases and the nested case-control study:
* patients without a prescription to an AED between January 1, 2000 and December 31, 2009
* patients who do not fulfill the quality criteria of the respective database
Exclusion Criteria for the additional descriptive studies comparing the study populations from GPRD and Danish data sources and cohort study:
* patients without a first prescription to at least one AED at July 1, 1996 or later in the UK or Denmark
* patients younger than age of 15 years at the index date
* patients who do not have a registration history of at least 6 months prior to the index date (first date of AED prescription)
* patients who have not fulfilled research data criteria in GPRD
* patients with records of coded suicidality (wide definition, including suicidal ideation) in the six months prior to the index date
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01607333
Study Brief:
Protocol Section:
NCT01607333