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Well-characterised and manageable safety profile1

The majority of nonhaematologic adverse reactions were Grade 1/21

  • The 3 most frequent nonhaematologic adverse drug reactions were bruising (21.3%), dizziness (15.0%), and headache (13.9%)1
  • Grade 3/4 adverse reactions occurred at a similar rate between the treatment and control arms2

Percentage of MF patients treated with JAKAVI with nonhaematologic adverse reactions (N=301)1,a

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

aMyelofibrosis patients randomised to and treated with ruxolitinib from the Phase III pivotal COMFORT-I and COMFORT-II studies.
bCommon Terminology Criteria for Adverse Events (CTCAE) version 3.0; Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening.
cFrequency is based on adverse event data. A subject with multiple occurrences of an adverse drug reaction (ADR) is counted only once in that ADR category. ADRs reported are on treatment or up to 28 days post-treatment end date.
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 post-treatment end date.

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; April 2015.
  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.