Table 2.
Pooled placebo subjects | Cohort 1, 0.1 mg kg−1 i.v. | Cohort 2, 0.3 mg kg−1 i.v. | Cohort 3, 1.0 mg kg−1 i.v. | Cohort 4, 3.0 mg kg−1 i.v. | Cohort 5, 10 mg kg−1 i.v. | Cohort 6, 3.0 mg kg−1 s.c. | Cohort 7, atopic subjects, 10 mg kg−1 i.v. | Combined | |
---|---|---|---|---|---|---|---|---|---|
Subjects treated (n) | 16 | 6 | 6 | 6 | 6 | 6 | 6 | 12 | 48 |
Total number of subjects with adverse events [n (%)] | 9 (56.3) | 5 (83.3) | 2 (33.3) | 6 (100.0) | 4 (66.7) | 5 (83.3) | 0 (0.0) | 10 (83.3) | 32 (66.7) |
Headache | 2 (12.5) | 3 (50.0) | 0 (0.0) | 1 (16.7) | 1 (16.7) | 1 (16.7) | 0 (0.0) | 2 (16.7) | 8 (16.7) |
Nasopharyngitis | 0 (0.0) | 3 (50.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 2 (16.7) | 6 (12.5) |
Back pain | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (33.3) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 3 (6.3) |
Diarrhoea | 1 (6.3) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 1 (16.7) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 3 (6.3) |
Oropharyngeal pain | 1 (6.3) | 1 (16.7) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (8.3) | 3 (6.3) |
Dizziness | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (8.3) | 2 (4.2) |
Vomiting | 0 (0.0) | 0 (0.0) | 1 (16.7) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (4.2) |
Epistaxis | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 1 (8.3) | 2 (4.2) |
Influenza-like illness | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (33.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (4.2) |
Erythema | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (4.2) |
Palpitations | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (4.2) |
Hypersensitivity | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (16.7) | 2 (4.2) |
Limb injury | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 2 (4.2) |
Myalgia | 1 (6.3) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (8.3) | 2 (4.2) |