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