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:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-24 @ 7:56 PM
NCT ID:
NCT05421104
Eligibility Criteria:
Inclusion Criteria:
Included patients:
* With at least one International Classification of Diseases, 9th Revision, Clinical Modification/International Classification of Diseases,10th Revision, Clinical Modification code for PV in the identification period (01-Apr-2007 until 30-Jun-2019) that had non-missing sex and year of birth data and who were treated as part of the Integrated Delivery Network
* That were ≥ 18 years old at PV diagnosis
* With ≥ 2 prescriptions of HU
* That were classified as resistant to or intolerant of HU after a minimum of 3 months HU treatment (index date), defined as:
HCT ≥ 45% with phlebotomy (last phlebotomy within last 3 months) or Platelet count \> 400 x 109/L and presence of palpable splenomegaly (palpable spleen up to 3 months after platelet count).
To identify patients in the RUX group:
\- With ≥ 2 prescriptions of RUX in the post-index period.
Exclusion Criteria:
Excluded patients:
\- With a MF or AML diagnosis prior to a PV diagnosis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05421104
Study Brief:
Protocol Section:
NCT05421104