Placebo | PRM-151 | All | ||||
1 mg·kg−1 | 5 mg·kg−1 | 10 mg·kg−1 | All doses | |||
Subjects | 6 | 6 | 5 | 4 | 15 | 21 |
Cough | 2 (33) | 4 (67) | 3 (60) | 0 (0) | 7 (47) | 9 (43) |
Productive cough | 2 (33) | 1 (17) | 2 (40) | 1 (25) | 4 (27) | 6 (29) |
Fatigue | 1 (17) | 0 (0) | 2 (40) | 1 (25) | 3 (20) | 4 (19) |
Headache | 1 (17) | 2 (33) | 0 (0) | 1 (25) | 3 (20) | 4 (19) |
Dyspnoea | 2 (33) | 2 (33) | 0 (0) | 0 (0) | 2 (13) | 4 (19) |
Dizziness | 1 (17) | 1 (17) | 1 (20) | 0 (0) | 2 (13) | 3 (14) |
Pruritus | 1 (17) | 1 (17) | 1 (20) | 0 (0) | 2 (13) | 3 (14) |
Haematoma | 1 (17) | 2 (33) | 0 (0) | 0 (0) | 2 (13) | 3 (14) |
Dyspnoea upon exertion | 2 (33) | 1 (17) | 0 (0) | 0 (0) | 1 (7) | 3 (14) |
Nasopharyngitis | 2 (33) | 1 (17) | 0 (0) | 0 (0) | 1 (7) | 3 (14) |
Back pain | 2 (33) | 0 (0) | 1 (20) | 0 (0) | 1 (7) | 3 (14) |
Dysphonia | 0 (0) | 2 (33) | 0 (0) | 0 (0) | 2 (13) | 2 (10) |
Hypotension | 0 (0) | 1 (17) | 0 (0) | 1 (25) | 2 (13) | 2 (10) |
Lymphadenopathy | 1 (17) | 1 (17) | 0 (0) | 0 (0) | 1 (7) | 2 (10) |
Catheter site haematoma | 1 (17) | 1 (17) | 0 (0) | 0 (0) | 1 (7) | 2 (10) |
Malaise | 1 (17) | 1 (17) | 0 (0) | 0 (0) | 1 (7) | 2 (10) |
Hypertension | 1 (17) | 1 (17) | 0 (0) | 0 (0) | 1 (7) | 2 (10) |
Noncardiac chest pain | 2 (33) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 2 (10) |
Vomiting | 2 (33) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 2 (10) |
Data are presented as n or n (%). Events reported by at least two (10%) out of the 21 subjects are listed. Treatment-emergent adverse events were defined as events occurring from the first day of dosing to the end of the study (day 57 or early termination day).