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Frequency category of adverse events with JAKAVI reported in the RESPONSE study[1]

Jakavi adverse events table in RESPONSE study
ADR, adverse drug reaction; BID, twice daily; CTCAE, Common Terminology Criteria for Adverse Events; RESPONSE, Randomized Study of Efficacy and Safety in Polycythemia Vera with JAK Inhibitor INCB018424 versus Best Supportive Care; ULN, upper limit normal.
aFrequency category for each adverse drug reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10), and uncommon (≥1/1000 to <1/100).
bFrequency is based on adverse event data. A subject with multiple occurrences of an ADR is counted only once in that ADR category. ADRs reported are on treatment or up to 28 days after treatment end date.
cFrequency is based on laboratory values. A subject with multiple occurrences of an ADR is counted only once in that ADR category. ADRs reported are on treatment or up to 28 days after treatment end date.
dCTCAE version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening.
eAny bleeding, including intracranial and gastrointestinal bleeding, bruising, and other bleeding.
fIncludes epistaxis, postprocedural haemorrhage, and haematuria.

Reference

  1. JAKAVI® (ruxolitinib) tablets: EU Summary of Product Characteristics. Novartis; August 2021.