Table 4 Summary of treatment-emergent AEs by treatment
| Â | Lucerastat | Placebo | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
2000Â mg | 4000Â mg | Day 1 | Day 3 | |||||||||
Day 1 | Day 3 | |||||||||||
N = 6 | N = 6 | N = 2 | N = 2 | |||||||||
nAEs | n | % | nAEs | n | % | nAEs | n | % | nAEs | n | % | |
Part A | ||||||||||||
Any PT | ||||||||||||
  Number of subjects with at least one AE |  | 1 | 16.7 |  |  |  |  | 1 | 50.0 |  |  |  |
  Number of different AEs | 2 |  |  |  |  |  | 2 |  |  |  |  |  |
  Total number of AEs | 2 |  |  |  |  |  | 2 |  |  |  |  |  |
Most common AEsa | ||||||||||||
  Nausea | – | – | – | – | – | – | 1 | 1 | 50.0 | – | – | – |
  Vomiting | – | – | – | – | – | – | 1 | 1 | 50.0 | – | – | – |
  Fatigue | 1 | 1 | 16.7 | – | – | – | – | – | – | – | – | – |
  Nasal congestion | 1 | 1 | 16.7 | – | – | – | – | – | – | – | – | – |
| Â | Lucerastat | Moxifloxacin | Placebo | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
1000Â mg | 4000Â mg | 400Â mg | Â | |||||||||
N = 36 | N = 36 | N = 35 | N = 36 | |||||||||
nAEs | n | (%) | nAEs | n | (%) | nAEs | n | (%) | nAEs | n | (%) | |
Part B | ||||||||||||
Any PT | ||||||||||||
  Number of subjects with at least one AE |  | 12 | 33.3 |  | 9 | 25.0 |  | 18 | 51.4 |  | 9 | 25.0 |
  Number of different AEs | 9 |  |  | 13 |  |  | 12 |  |  | 9 |  |  |
  Total number of AEs | 16 |  |  | 17 |  |  | 30 |  |  | 12 |  |  |
Most common AEsa | ||||||||||||
  Headache | 4 | 4 | 11.1 | 3 | 2 | 5.6 | 4 | 4 | 11.4 | 4 | 4 | 11.1 |
  Dizziness | 2 | 2 | 5.6 | 2 | 2 | 5.6 | 4 | 4 | 11.4 | – | – | – |
  Nausea | – | – | – | – | – | – | 6 | 6 | 17.1 | – | – | – |
  Medical device site reaction | 3 | 3 | 8.3 | – | – | – | 1 | 1 | 2.9 | 1 | 1 | 2.8 |
  Electrocardiogram QT prolonged | – | – | – | 1 | 1 | 2.8 | 8 | 3 | 8.6 | – | – | – |
  Catheter site pain | – | – | – | 2 | 2 | 5.6 | 1 | 1 | 2.9 | – | – | – |
  Catheter site related reaction | 2 | 2 | 5.6 | 1 | 1 | 2.8 | – | – | – | – | – | – |