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. 2020 Jan 30;33(1):15–20. doi: 10.1089/jamp.2018.1507

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.