Table 3.
Adverse events that occurred in ≥ 2% of the combined MEDI-528 group (safety population)
|
Adverse event, n (%) of subjects |
|
MEDI-528 |
|||
|---|---|---|---|---|---|
| |
Placebo |
30 mg |
100 mg |
300 mg |
Combined |
| (n = 82) | (n = 81) | (n = 83) | (n = 81) | (n = 245) | |
| Asthma |
25 (30.5) |
30 (37.0) |
21 (25.3) |
31 (38.3) |
82 (33.5) |
| Upper respiratory tract infection |
12 (14.6) |
6 (7.4) |
16 (19.3) |
20 (24.7) |
42 (17.1) |
| Headache |
8 (9.8) |
13 (16.0) |
5 (6.0) |
6 (7.4) |
24 (9.8) |
| Nasopharyngitis |
12 (14.6) |
11 (13.6) |
5 (6.0) |
7 (8.6) |
23 (9.4) |
| Sinusitis |
4 (4.9) |
10 (12.3) |
4 (4.8) |
6 (7.4) |
20 (8.2) |
| Influenza |
6 (7.3) |
10 (12.3) |
5 (6.0) |
2 (2.5) |
17 (6.9) |
| Urinary tract infection |
6 (7.3) |
7 (8.6) |
7 (8.4) |
2 (2.5) |
16 (6.5) |
| Pharyngitis |
2 (2.4) |
4 (4.9) |
8 (9.6) |
4 (4.9) |
16 (6.5) |
| Bronchitis |
8 (9.8) |
4 (4.9) |
2 (2.4) |
5 (6.2) |
11 (4.5) |
| Injection site erythema |
2 (2.4) |
1 (1.2) |
4 (4.8) |
5 (6.2) |
10 (4.1) |
| Allergic rhinitis |
7 (8.5) |
5 (6.2) |
1 (1.2) |
3 (3.7) |
9 (3.7) |
| Gastroenteritis |
3 (3.7) |
2 (2.5) |
5 (6.0) |
2 (2.5) |
9 (3.7) |
| Diarrhea |
2 (2.4) |
3 (3.7) |
3 (3.6) |
3 (3.7) |
9 (3.7) |
| Rhinitis |
5 (6.1) |
3 (3.7) |
3 (3.6) |
2 (2.5) |
8 (3.3) |
| Back pain |
2 (2.4) |
3 (3.7) |
3 (3.6) |
2 (2.5) |
8 (3.3) |
| Pneumonia |
0 (0.0) |
5 (6.2) |
0 (0.0) |
3 (3.7) |
8 (3.3) |
| Dizziness |
5 (6.1) |
2 (2.5) |
5 (6.0) |
0 (0.0) |
7 (2.9) |
| Injection site pain |
5 (6.1) |
1 (1.2) |
4 (4.8) |
2 (2.5) |
7 (2.9) |
| Rash |
3 (3.7) |
2 (2.5) |
1 (1.2) |
4 (4.9) |
7 (2.9) |
| Acute sinusitis |
2 (2.4) |
3 (3.7) |
2 (2.4) |
2 (2.5) |
7 (2.9) |
| Hypertension |
2 (2.4) |
4 (4.9) |
3 (3.6) |
0 (0.0) |
7 (2.9) |
| Pain in extremity |
2 (2.4) |
1 (1.2) |
3 (3.6) |
3 (3.7) |
7 (2.9) |
| Cough |
0 (0.0) |
2 (2.5) |
2 (2.4) |
3 (3.7) |
7 (2.9) |
| Oropharyngeal pain |
0 (0.0) |
2 (2.5) |
3 (3.6) |
2 (2.5) |
7 (2.9) |
| Pyrexia |
0 (0.0) |
0 (0.0) |
4 (4.8) |
3 (3.7) |
7 (2.9) |
| Migraine |
1 (1.2) |
4 (4.9) |
1 (1.2) |
1 (1.2) |
6 (2.4) |
| Pruritus |
1 (1.2) |
1 (1.2) |
2 (2.4) |
3 (3.7) |
6 (2.4) |
| Toothache |
1 (1.2) |
2 (2.5) |
4 (4.8) |
0 (0.0) |
6 (2.4) |
| Nasal congestion |
0 (0.0) |
2 (2.5) |
3 (3.6) |
1 (1.2) |
6 (2.4) |
| Pharyngotonsillitis |
0 (0.0) |
5 (6.2) |
0 (0.0) |
1 (1.2) |
6 (2.4) |
| Bacterial upper respiratory tract infection |
0 (0.0) |
2 (2.5) |
2 (2.4) |
2 (2.5) |
6 (2.4) |
| Asthenia |
2 (2.4) |
3 (3.7) |
1 (1.2) |
1 (1.2) |
5 (2.0) |
| Malaise |
1 (1.2) |
0 (0.0) |
3 (3.6) |
2 (2.5) |
5 (2.0) |
| Dyspepsia |
0 (0.0) |
3 (3.7) |
1 (1.2) |
1 (1.2) |
5 (2.0) |
| Musculoskeletal pain |
0 (0.0) |
1 (1.2) |
4 (4.8) |
0 (0.0) |
5 (2.0) |
| Bacterial pharyngitis | 0 (0.0) | 2 (2.5) | 1 (1.2) | 2 (2.5) | 5 (2.0) |