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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT06991894
Eligibility Criteria:
Inclusion and exclusion criteria for the safety population:
Inclusion criteria:
* Patients with:
* At least one confirmed diagnosis of AA registered during the baseline period, or
* At least one confirmed diagnosis of idiopathic thrombocytopenic purpura (International Classification of Diseases, 10th Revision \[ICD10\] code: D69.3) registered before the index date and at least one confirmed diagnosis of AA during the follow-up period.
* Had at least 6 months of continuous enrolment prior to the index date.
Confirmed diagnosis was defined as having ≥1 inpatient or ≥2 outpatient claims with a relevant ICD-10 code and without any doubtful flag.
Continuous enrolment (being continuously followed in the database) was defined as having at least one claim every semester.
Exclusion Criteria:
* Not receiving ATG, CSA, ETB or romiplostim (ROM) during the selection period,
* Had a diagnosis of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), myelofibrosis, other hematological malignancies, or cataract before the index date.
Inclusion and exclusion criteria for the effectiveness population:
Inclusion criteria:
* Had at least one confirmed diagnosis of AA registered before the index date,
* Had at least one procedure for any type of transfusion such as red blood cell transfusion, platelet transfusion, or granulocyte transfusion registered during the baseline period or within 4 weeks after the index date,
* Had at least 6 months of continuous enrolment prior to the index date,
* Had at least a 6-month follow-up period.
Exclusion criteria:
* Not receiving ATG, CSA, ETB or ROM during the selection period,
* Had at least one prescription of ATG, CSA, ETB or ROM before the index date,
* Had a diagnosis of AML, CMML or other hematological malignancies before the index date.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
90 Years
Study:
NCT06991894
Study Brief:
Protocol Section:
NCT06991894