This is an observational safety study being conducted in Europe comparing patients taking Xagrid to patients taking other cytoreductive treatments. The plan is to enrol at least 750 subjects taking Xagrid with up to 3000 subjects taking other cytoreductive therapies. The study will collect follow up data for 5 years for each patient enrolled that will focus on collecting data related to pre-defined events (PDEs) and Suspected Serious Adverse Reactions (SSARs).
Study Type
OBSERVATIONAL
Enrollment
3,647
Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies
Pre-defined events (PDEs) were evaluated whenever an event occurred and was defined by a panel of independent qualified physicians, blinded to cytoreductive therapy, validated all PDEs prior to analysis (Event Validation Panel). Non-PDE death only included deaths not recorded as outcome of another PDE.
Time frame: Up to 5 years
Number of Participants With Suspected Serious Adverse Reaction (SSAR) Events
SSAR: serious adverse event (SAE) that was considered related to cytoreductive therapy. SAE: any untoward medical occurrence that at any dose resulted in death, life-threatening (at the time of the event), in-patient hospitalization/prolongation of existing hospitalization (elective hospitalizations/procedures for pre-existing conditions that had not worsened were excluded), resulted in persistent or significant disability/incapacity or congenital abnormality/birth defect. Relatedness (suspected/not suspected) to XAGRID or other cytoreductive theraphy was determined by the investigator. As for SSARs, it was important to consider whether the events were related to XAGRID or other cytoreductive therapy. A participant was included in Xagrid or other treatment group based on treatment exposure, participants received Xagrid + Other was counted both in Xagrid and other treatment group.
Time frame: Up to 5 years
Event Rate of Thrombohaemorrhagic Events
Event Rate of Thrombohaemorrhagic Events was calculated by dividing number of participants with events by total patient-year exposure. The reporting unit is per 100 participant-years of treatment exposure. Thrombohaemorrhagic Events is a composite endpoint of the PDEs myocardial infarction, angina, stroke, transient ischaemic attack, venous thromboembolic events, intermittent claudication/digital ischaemia, and major haemorrhagic events.
Time frame: Up to 5 years
Platelet Count
Time frame: Baseline, Month 6,12,18, 24, 30, 36, 42, 48, 54, 60
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Clinic of Haematology
Limassol, Cyprus
Rigshospitalet
Copenhagen, Denmark
SUS-Esbjerg Maematologisk afdelning
Esbjerg, Denmark
Herlev Hospital
Herlev, Denmark
Odense University Hospital
Odense, Denmark
Roskilde Sygehus
Roskilde, Denmark
Vejle Sygehus
Vejle, Denmark
Viborg Hospital
Viborg, Denmark
Helsinki University Hospital
Helsinki, Finland
Jyvaskyla Central Hospital
Jyväskylä, Finland
...and 154 more locations
Duration of Exposure for Each Essential Thrombocythemia (ET) Therapy
Total duration for each participant = sum of \[stop date - start date + 1\] across all periods of time where the specific treatment was taken during the study, where start date = registration/consent date for treatments started before registration/consent date and/or stop date withdrawal/final date for treatments ongoing at the time of withdrawal/end of study. Where a participant has multiple records of the same therapy on the same day, the therapy is counted once for that day.
Time frame: Up to 5 years
Cumulative Dose for Each Essential Thrombocythemia (ET) Therapy
Since the study is observational nature, interpreting the table is difficult due to inconsistencies in reporting the units of the dose.
Time frame: Up to 5 years