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Table 2 Most Frequently Reported Adverse Events in Study 1 (Safety Population*)

From: Safety profile and clinical activity of multiple subcutaneous doses of MEDI-528, a humanized anti-interleukin-9 monoclonal antibody, in two randomized phase 2a studies in subjects with asthma

 

No. (%) of Subjects

Event

 

MEDI-528

 

Placebo

(n = 9)

0.3 mg/kg

(n = 9)

1 mg/kg

(n = 9)

3 mg/kg

(n = 9)

Total

(n = 27)

Blood glucose increase

3 (33.3)

5 (55.6)

2 (22.2)

1 (11.1)

8 (29.6)

Nasopharyngitis

4 (44.4)

3 (33.3)

1 (11.1)

2 (22.2)

6 (22.2)

Blood bicarbonate decrease

1 (11.1)

1 (11.1)

2 (22.2)

3 (33.3)

6 (22.2)

Injection site pain

0 (0.0)

3 (33.3)

0 (0.0)

3 (33.3)

6 (22.2)

Pharyngolaryngeal pain

1 (11.1)

2 (22.2)

3 (33.3)

0 (0.0)

5 (18.5)

Lymphocyte count decrease

0 (0.0)

0 (0.0)

4 (44.4)

1 (11.1)

5 (18.5)

Injection site bruising

1 (11.1)

0 (0.0)

1 (11.1)

3 (33.3)

4 (14.8)

Presence of protein in urine

1 (11.1)

2 (22.2)

1 (11.1)

1 (11.1)

4 (14.8)

Vomiting

3 (33.3)

0 (0.0)

1 (11.1)

1 (11.1)

2 (7.4)

Urinary tract infection

2 (22. 2)

1 (11.1)

0 (0.0)

1 (11.1)

2 (7.4)

Presence of blood in urine

1 (11.1)

1 (11.1)

1 (11.1)

0 (0.0)

2 (7.4)

Blood chloride increase

2 (22.2)

1 (11.1)

0 (0.0)

0 (0.0)

1 (3.7)

Blood potassium decrease

2 (22.2)

0 (0.0)

1 (11.1)

0 (0.0)

1 (3.7)

Influenza

2 (22.2)

0 (0.0)

1 (11.1)

0 (0.0)

1 (3.7)

Lipase increase

2 (22.2)

1 (11.1)

0 (0.0)

0 (0.0)

1 (3.7)

Sinusitis

2 (22.2)

0 (0.0)

1 (11.1)

0 (0.0)

1 (3.7)

  1. Values are shown in descending order of frequency in the total MEDI-528 group.
  2. *Consisted of all subjects who received the study drug.
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