TABLE 4

Adverse events: study 2

System organ class preferred term#Tiotropium (18 µg)
+
RPL554 (1.5 mg)
Tiotropium (18 µg)
+
RPL554 (6 mg)
Tiotropium (18 µg)
+
placebo
EventsPatientsEventsPatientsEventsPatients
Subjects292728
Total TEAEs1612 (41.4)2012 (44.4)1712 (42.9)
General disorders and administration site conditions54 (13.8)44 (14.8)76 (21.4)
Medical device site reaction44 (13.8)11 (3.7)44 (14.3)
Chest discomfort11 (3.4)11 (3.7)22 (7.1)
Nervous system disorders22 (6.9)85 (18.5)33 (10.7)
Headache22 (6.9)85 (18.5)33 (10.7)
Respiratory, thoracic and mediastinal disorders33 (10.3)33 (11.1)32 (7.1)
Dyspnoea11 (3.4)11 (3.7)32 (7.1)
Infections and infestations11 (3.4)11 (3.7)32 (7.1)
Musculoskeletal and connective tissue disorders22 (6.9)22 (7.4)00

Data are presented as n or n (%). TEAE: treatment emergent adverse event. TEAEs reported by more than one patient are presented. Patients may have experienced the same adverse event following different study treatments. #: MedDRA terms (www.meddra.org).