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) |