BACK OF THE BOOK
April 23 – 26, 2015
April 29 – May 2, 2015
May 29 – June 2, 2015
June 11 – 14, 2015
Oncology Nursing Society’s 40th Annual
Congress
International Symposium on
Myelodysplastic Syndromes
2015 American Society of Clinical
Oncology Annual Meeting
20th Congress of the European
Hematology Association
Orlando, FL
The goal of this year’s annual congress is to provide oncology nursing professionals with information about the
latest developments in the field and quality cancer care
through interactive learning experiences and networking
opportunities.
Washington, DC
The 13th International Symposium, presented by the
MDS Foundation, will focus on advancing research and
patient care in the area of MDS.
Chicago, IL
At the 2015 ASCO Annual Meeting, more than 25,000
oncology professionals will explore the theme of “Illumination & Innovation: Transforming Data into Learning”
through scientific presentations and comprehensive
educational content.
Vienna, Austria
The EHA Annual Congress will provide a forum for
presenting original unpublished data and sharing ideas
for hematologic innovation, as well as disseminating
evidence-based knowledge of primary clinical relevance.
June 20 – June 25, 2015
International Society on Thrombosis
and Haemostasis Annual Meeting
Table 2 (continued)
Additional important adverse reactions that did not meet
the threshold criteria for inclusion in Table 2 were:
Immune system disorders
Cytokine release
syndrome
11
1
Infections and infestations
Other pathogen
infections
44
25
Bacterial infections
19
12
Fungal infections
15
7
Viral infections
13
4
Pneumonia
9
8
Sepsis
7
6
Increased alanine
aminotransferase
12
6
Increased aspartate
aminotransferase
11
4
Increased weight
11
0
Investigations
Metabolism and nutrition disorders
Hypokalemia
23
6
Hypomagnesemia
12
0
Hyperglycemia
11
7
Decreased appetite
10
3
Hypophosphatemia
6
5
Musculoskeletal and connective tissue disorders
Back pain
14
2
Pain in extremity
12
1
Bone pain
11
3
Arthralgia
10
2
Nervous system disorders
Headache
36
3
Tremor3
20
1
Dizziness
14
<1
Psychiatric disorders
Insomnia
15
0
Respiratory, thoracic, and mediastinal disorders
Cough
Dyspnea
19
4
0
15
5
Skin and subcutaneous tissue disorders
Rash
21
2
Hypotension
11
2
Hypertension
8
5
5
Vascular disorders
1
Grading based on NCI Common Terminology Criteria for
Adverse Events (CTCAE) version 4.0.
2
Diarrhea includes the following terms: colitis, diarrhea,
enteritis, and neutropenic colitis.
3
Tremor includes the following terms: resting tremor
and tremor.
4
5
Dyspnea includes the following terms: acute respiratory
failure, bronchial hyperactivity, bronchospasm, dyspnea,
dyspnea exertional, respiratory distress, respiratory
failure, and wheezing.
Rash includes the following terms: erythema, rash,
erythematous rash, generalized rash, macular rash,
maculo-papular rash, papular rash, and vesicular rash.
Blood and lymphatic system disorders: leukocytosis (2%),
lymphopenia (1%), Cardiac disorders: tachycardia (8%),
General disorders and administration site conditions:
edema (5%), Immune system disorders: cytokine storm
(1%), Investigations: decreased immunoglobulins (9%),
increased blood bilirubin (8%), increased gammaglutamyl-transferase (6%), increased liver enzymes (1%),
Metabolism and nutrition disorders: tumor lysis syndrome
(4%), hypoalbuminemia (4%), Nervous system disorders:
encephalopathy (5%), paresthesia (5%), aphasia (4%),
convulsion (2%), memory impairment (2%), cognitive
disorder (1%), speech disorder (< 1%), Psychiatric
disorders: confusion (7%), disorientation (3%), Vascular
disorders: capillary leak syndrome (< 1%). Hypersensitivity
reactions related to BLINCYTO™ treatment were
hypersensitivity (1%) and bronchospasm (< 1%).
6.2
Immunogenicity
As with all therapeutic proteins, there is potential for
immunogenicity. The immunogenicity of BLINCYTO™ has been
evaluated using either an electrochemiluminescence detection
technology (ECL) or an enzyme-linked immunosorbent assay
(ELISA) screening immunoassay for the detection of binding
anti-blinatumomab antibodies. For patients whose sera
tested positive in the screening immunoassay, an in vitro
biological assay was performed to detect neutralizing
antibodies.
In clinical studies, less than 1% of patients treated with
BLINCYTO™ tested positive for binding anti-blinatumomab
antibodies. All patients who tested positive for binding
antibodies also tested positive for neutralizing antiblinatumomab antibodies.
Anti-blinatumomab antibody