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
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.