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Well-characterised and manageable safety profile1

The majority of nonhaematologic adverse reactions were Grade 1/22

  • The 3 most frequent nonhaematologic adverse drug reactions were bruising (21.3%), dizziness (15.3%), and headache (14.0%)1
  • Grade 3/4 adverse reactions occurred at a similar rate between the treatment and control arms2

Frequency category of adverse events with JAKAVI reported in the COMFORT studies1,a

The majority of nonhematologic adverse reactions were Grade 1/2 - JAKAVI

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 all patients exposed to ruxolitinib in clinical studies (N=4755).
dFrequency 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.
eCTCAE version 3.0; Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening.
 fAny bleeding, including intracranial and gastrointestinal bleeding, bruising, and other bleeding.
gIncludes epistaxis, postprocedural haemorrhage, and haematuria.

JAKAVI had a manageable safety profile with 45.2% of patients remaining on treatment after >3 years3

Next: Haematologic adverse reactions

COMFORT=Controlled Myelofibrosis Study with Oral JAK Inhibitor Treatment.

References:

  1. JAKAVI® (ruxolitinib) tablets: EU Summary of Product Characteristics. Novartis; May 2017.
  2. Verstovsek S, Mesa RA, Gotlib J, et al. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med. 2012;366(9):799-807.
  3. Cervantes F, Vannucchi AM, Kiladjian J-J, et al; for the COMFORT-II investigators. Three-year efficacy, safety, and survival findings from COMFORT-II, a phase 3 study comparing ruxolitinib with best available therapy for myelofibrosis. Blood. 2013;122(25):4047-4053.