Blood and Lymph Conditions

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Polycythemia Vera

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Patients with clinically overt PV (and not exhibiting any of the characteristics listed for Cohort B), managed with:

1. Watchful waiting (with or without aspirin)\*, or
2. Phlebotomy (PHL) alone (with or without aspirin)\* - or
3. HU alone (without concomitant PHL, with or without aspirin).

(\*Unless patient has a history of intolerance or clinical resistance/ refractoriness to hydroxyurea \[HU\] (as assessed by the treating physician) - in which case, s/he belongs to Cohort B)

Patients with clinically overt PV, with one or more of the following disease characteristics:

1. Treatment with HU and PHL in combination or
2. Treatment with any agent other than HU or aspirin (e.g., recombinant interferon (IFN) or pegylated IFN preparations, busulfan, anagrelide) or
3. A history of thrombosis (venous or arterial) or
4. A history of intolerance or clinical resistance/ refractoriness to HU (as assessed by the treating physician) or
5. Presence of documented splenomegaly (clinically assessed by palpation) or
6. Presence of one or more of the following uncontrolled symptoms related to PV despite therapy (Symptoms deemed uncontrolled as per physician's judgment)

   1. Tiredness
   2. Difficulty sleeping
   3. Itching
   4. Muscle aches and/or bone pain
   5. Night sweats
   6. Sweats while awake
   7. Other

Robyn M. Scherber, MD, MPH

This is a Phase IV, multicenter, non-interventional, non-randomized, prospective, observational study in an adult population (patients \>18 years old) of men and women who have been diagnosed with clinically overt PV and are being followed in either community or academic medical centers in the United States who will be enrolled over a 12-month period and observed for 36 months from the date the last patient is enrolled.

Blood sample(s), two vials, one with heparin, another with ethylenediaminetetraacetic acid (EDTA) will be collected at enrollment and then annually thereafter until the end of study for serum analysis of proteins and assessment of allele burden and mutations.

Prospective Observational Study Of Patients With Polycythemia Vera In US Clinical Practices (REVEAL)

Prospective, Non-interventional Study of Disease Progression and Treatment of Patients With Polycythemia Vera in United States Academic or Community Clinical Practices

Healthcare resources were defined as a. Medical visits (including Office visits, ER visits, and hospitalizations), b. phlebotomy (PHL) procedures and c. prescriptions (including PV-related prescriptions, PV-related over-the-counter (OTC) medications, and prescription medications for co-morbid conditions).

The MPN-SAF TSS is a validated 10-item instrument that efficiently assesses the prevalence and severity of PV symptoms in both clinical practice and trial settings. Higher scores indicate more severe symptoms and greater inactivity with a possible total score range of 0-100.

WPAI-SHP is a validated 6-item instrument that measures the effect of overall health and specific symptoms on productivity at work and outside of it. All outcomes are presented as a proportion, with 0% representing minimal/no impairment and 100% representing maximal impairment or productivity loss.

The amount of health care received by a paid healthcare worker or by an unpaid caregiver

A patients self-reported assessment of burden including pain at site, difficulty and inconvenience of scheduling and cost factors.

Spots Global Cancer Trial Database for antisickling agents