ASH Clinical News March 2015 | Page 27

CLINICAL NEWS

“n our opinion, the long-term response
I
is mainly dependent on the effect of
rituximab. rhTPO showed little benefit
on sustained response.”

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 ant