ASH Clinical News November 2015 | Page 29

CLINICAL NEWS CMS/ONC Issues Final Rules on Electronic Health Records Incentive Program, Eases Mandates on Meaningful Use Ofatumumab has been previously approved in the United States for use in combination with chlorambucil for the treatment of treatment-naïve CLL patients for whom fludarabine-based therapy is not appropriate. The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) released final Source: Genmab press release, September 19, 2015. Table 5: Most Frequently Reported Non-hematologic Adverse Reactions (Regardless of Relationship to Study Drug) in Patients with Newly Diagnosed Ph+ CML-CP (≥10% in Tasigna 300 mg Twice-Daily or Imatinib 400 mg Once-Daily Groups) 60-Month Analysisa rules for the Electronic Health Records (EHRs) Incentive Programs that simplify requirements and add new flexibilities for providers who have not yet met “mean- Table 6: Most Frequently Reported Non-hematologic Adverse Reactions in Patients with Resistant or Intolerant Ph+ CML Receiving Tasigna 400 mg Twice-Daily (Regardless of Relationship to Study Drug) (≥10% in any Group) 24-Month Analysisa Patients with Newly Diagnosed Ph+ CML-CP TASIGNA Imatinib TASIGNA Imatinib 300 mg 400 mg 300 mg 400 mg twiceoncetwiceoncedaily daily daily daily N=279 Body System and Preferred Term N=280 All Grades (%) N=279 N=280 CTC Gradesb 3/4 (%) General disorders Fatigue and administration Pyrexia site conditions Asthenia Peripheral edema Face edema 23 14 14 9 <1 20 13 12 20 14 1 <1 <1 <1 0 1 0 0 0 <1 Musculoskeletal and connective tissue disorders Myalgia Arthralgia Muscle spasms Pain in extremity Back pain 19 22 12 15 19 19 17 34 16 17 <1 <1 0 <1 1 <1 <1 1 <1 1 Respiratory, thoracic and mediastinal disorders Cough Oropharyngeal pain Dyspnea 17 13 0 0 12 11 6 6 0 2 0 <1 Infections and infestations Nasopharyngitis Upper respiratory tract infection Influenza Gastroenteritis 27 21 0 0 17 13 7 14 9 10 <1 0 0 0 0 <1 Eye disorders Eyelid edema Periorbital edema 1 <1 19 15 0 0 <1 0 Psychiatric disorders Insomnia 11 9 0 0 10 4 1 <1 Vascular disorder Hypertension a Excluding laboratory abnormalities b NCI Common Terminology Criteria for Adverse Events, Version 3.0 Table 6: Most Frequently Reported Non-hematologic Adverse Reactions in Patients with Resistant or Intolerant Ph+ CML Receiving Tasigna 400 mg Twice-Daily (Regardless of Relationship to Study Drug) (≥10% in any Group) 24-Month Analysisa CML-CP CML-AP N=321 Body System and Preferred Term N=137 All Grades (%) CTC Gradesb 3/4 (%) All Grades (%) CTC Gradesb 3/4 (%) Skin and subcutaneous tissue disorders Rash Pruritus Night sweat Alopecia 36 32 12 11 2 <1 <1 0 29 20 27 12 0 0 0 0 Gastrointestinal disorders Nausea Constipation Diarrhea Vomiting Abdominal pain Abdominal pain upper Dyspepsia 37 26 28 29 15 1 <1 3 <1 2 22 19 24 13 16 <1 0 2 0 3 14 10 <1 <1 12 4 <1 0 Headache 35 2 20 1 32 22 16 15 3 <1 0 <1 23 28 14 12 <1 2 1 0 Nervous system disorders General disorders Fatigue and administration Pyrexia site conditions Asthenia Peripheral edema (continued) CML-CP CML-AP N=321 Body System and Preferred Term N=137 All Grades (%) CTC Gradesb 3/4 (%) All