Table 2.
Drug-Related Treatment-Emergent Adverse Events
|
All |
Cohort 1 |
Cohort 2 |
Cohort 3 |
Cohort 4 |
Cohort 5 |
Cohort 6 |
---|---|---|---|---|---|---|---|
|
Placebo |
Active |
Active |
Active |
Active |
Active |
Active |
System organ class |
Subjects |
25 mg |
50 mg |
100 mg |
100 mg |
100 mg |
100 mg |
Preferred term | (N = 8) | (N = 6) | (N = 6) | (N = 6) | (N = 6) | (N = 6) | (N = 6) |
Subjects with at least one drug-related TEAE | 0 | 3 (50%) | 2 (33%) | 3 (50%) | 1 (17%) | 1 (17%) | 2 (33%) |
Respiratory, thoracic, and mediastinal disorders | |||||||
Cough | 0 | 1 (17%) | 1 (17%) | 3 (50%) | 1 (17%) | 1 (17%) | 1 (17%) |
Possibly related | 0 | 1 (100%) | 0 | 0 | 0 | 0 | 1 (100%) |
Probably related | 0 | 0 | 1 (100%) | 3 (100%) | 1 (100%) | 1 (100%) | 0 |
Increased upper airway secretion | 0 | 2 (33%) | 0 | 0 | 0 | 0 | 0 |
Possibly related | 0 | 2 (100%) | 0 | 0 | 0 | 0 | 0 |
Probably related | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Dysphonia | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17%) |
Possibly related | 0 | 0 | 0 | 0 | 0 | 0 | 1 (100%) |
Probably related | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Nervous system disorders | |||||||
Headache | 0 | 0 | 1 (17%) | 0 | 0 | 0 | 1 (17%) |
Possibly related | 0 | 0 | 1 (100%) | 0 | 0 | 0 | 1 (100%) |
Probably related | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Dizziness | |||||||
Possibly related | 0 | 0 | 1 (100%) | 0 | 0 | 0 | 0 |
Probably related | 0 | 0 | 0 | 0 | 0 | 0 | 1 (100%) |
Severity was mild in all events with the exception of headache in IPF cohort that was moderate. This event occurred 5 hours after drug was administered and lasted for 2 days. All other related AEs were transient.
TEAE, treatment-emergent adverse event; IPF, idiopathic pulmonary fibrosis; AE, adverse event.