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.