Table 2.
Most Frequently Reported Adverse Events in Study 1 (Safety Population*)
| 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) |
Values are shown in descending order of frequency in the total MEDI-528 group.
*Consisted of all subjects who received the study drug.