Safety
irritability, thoracic pain, headache, pain
ADVERSE EVENTS, EVENTS, HYPOGLYCEMIA, HERPES ZOSTER
During the first 6 months of therapy, 109 adverse events occurred in 24/28 patients. All of these AEs were grade 1 to 3, and no grade 4 or 5 events occurred. Eleven patients experienced at least one grade 3 AE, eight patients only grade 1 and 2 events, and five patients only experienced grade 1 events. Patients had a median of 3.0 events during the first 6 months of treatment (including the 4 without any such AEs). Of all 109 events, only 12 (11%) were grade 3, 31 (28%) were grade 2, and the majority (66/109 = 61%) were grade 1. Frequencies of AEs that occurred in more than 10% of the patients can be found in Table AEs occurring in > 10% of patients (i.e., at least in 3 patients)Fifty of all 109 AEs were deemed not to be related to the study treatment according to the treating physician. Relationship to ruxolitinib in the remaining adverse events was determined to be related (Only two patients had to interrupt treatment because of AEs (one case of irritability, one case of back pain). Both of them were re-exposed and subsequently remained on drug treatment without any dose reduction. Four dose reductions were due to AEs (one case each of elevation of transaminases, thoracic pain, hypoglycemia, and headache). No patient permanently discontinued treatment during 6 months of therapy.Eight severe adverse events (SAEs) occurred in five patients. However, only one SAE was interpreted as clearly related to ruxolitinib (herpes zoster), another case was considered possibly related (thoracic pain), while all other SAEs were considered to be unrelated according to the treating physician.