TABLE 2

Adverse events

PlaceboPRM-151All
1 mg·kg−15 mg·kg−110 mg·kg−1All doses
Subjects66541521
Cough2 (33)4 (67)3 (60)0 (0)7 (47)9 (43)
Productive cough2 (33)1 (17)2 (40)1 (25)4 (27)6 (29)
Fatigue1 (17)0 (0)2 (40)1 (25)3 (20)4 (19)
Headache1 (17)2 (33)0 (0)1 (25)3 (20)4 (19)
Dyspnoea2 (33)2 (33)0 (0)0 (0)2 (13)4 (19)
Dizziness1 (17)1 (17)1 (20)0 (0)2 (13)3 (14)
Pruritus1 (17)1 (17)1 (20)0 (0)2 (13)3 (14)
Haematoma1 (17)2 (33)0 (0)0 (0)2 (13)3 (14)
Dyspnoea upon exertion2 (33)1 (17)0 (0)0 (0)1 (7)3 (14)
Nasopharyngitis2 (33)1 (17)0 (0)0 (0)1 (7)3 (14)
Back pain2 (33)0 (0)1 (20)0 (0)1 (7)3 (14)
Dysphonia0 (0)2 (33)0 (0)0 (0)2 (13)2 (10)
Hypotension0 (0)1 (17)0 (0)1 (25)2 (13)2 (10)
Lymphadenopathy1 (17)1 (17)0 (0)0 (0)1 (7)2 (10)
Catheter site haematoma1 (17)1 (17)0 (0)0 (0)1 (7)2 (10)
Malaise1 (17)1 (17)0 (0)0 (0)1 (7)2 (10)
Hypertension1 (17)1 (17)0 (0)0 (0)1 (7)2 (10)
Noncardiac chest pain2 (33)0 (0)0 (0)0 (0)0 (0)2 (10)
Vomiting2 (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).