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Safety Profile

The following data reflect exposure to WINREVAIR in the pivotal STELLAR trial.

Adverse reactions occurring in STELLAR by the time all patients completed the primary 24-week period of the study are summarized below.

Adverse reactions in patients receiving WINREVAIR (DBPC + LTDB)a:

aDouble-blind placebo-controlled period + long-term double-blind period.
bComposite terms.

Increased hemoglobin

The majority of events of increased hemoglobin (Hgb increased, polycythemia) were non-serious, mild, and reversible, and were not associated with discontinuation of therapy.

Thrombocytopenia

The majority of events of thrombocytopenia (thrombocytopenia and platelet count decreased) were non-serious, mild, reversible, and have not been associated with discontinuation of therapy.

Telangiectasia

Events of telangiectasia were non-serious and did not progress in severity over time.

Increased blood pressure

Events of increased blood pressure (hypertension, blood pressure diastolic increased, blood pressure increased) were non-serious and no severe events were reported.

Treatment discontinuation

The overall incidence of treatment discontinuations due to an adverse reaction was 4% in the WINREVAIR group and 7% in the placebo group.

There were no specific adverse reactions causing treatment discontinuations that occurred with a frequency greater than 1% and more often in the WINREVAIR group.

Long-term safety data

Long-term safety data are available from a Phase 2 clinical trial (PULSAR) that comprised a 24-week, double-blind, placebo-controlled treatment period followed by a 30-month, open-label extension period (n=104). A majority of these patients then continued into a long-term follow-up study.

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