Table 2.
Overall summary of number of subjects with TEAEs: SD1
| n (%) | Placebo (n = 13) | Vericiguat dose (oral PEG solution) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| 0.5 mg (n = 7) | 1.0 mg (n = 8) | 2.5 mg (n = 8) | 5.0 mg non-smokers (n = 7) | 5.0 mg smokers (n = 6) | 7.5 mg (n = 8) | 10.0 mg (n = 8) | 15.0 mg (n = 4) | ||
| Any AE | 3 (23.1) | 1 (14.3) | 2 (25.0) | 3 (37.5) | 5 (71.4) | 3 (50.0) | 4 (50.0) | 5 (62.5) | 4 (100.0) |
| Any study drug-related AE | 1 (7.7) | 0 | 1 (12.5) | 3 (37.5) | 3 (42.9) | 1 (16.7) | 4 (50.0) | 4 (50.0) | 4 (100.0) |
| Any AE related to procedures | 1 (7.7) | 1 (14.3) | 0 (0.0) | 2 (25.0) | 1 (14.3) | 0 | 0 | 2 (25.0) | 3 (75.0) |
| Maximum intensity | |||||||||
| Mild | 3 (23.1) | 1 (14.3) | 2 (25.0) | 3 (37.5) | 5 (71.4) | 3 (50.0) | 4 (50.0) | 5 (62.5) | 3 (75.0) |
| Moderate | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (25.0) |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Maximum intensity for study drug-related AEs | |||||||||
| Mild | 1 (7.7) | 0 | 1 (12.5) | 3 (37.5) | 3 (42.9) | 1 (16.7) | 4 (50.0) | 4 (50.0) | 3 (75.0) |
| Moderate | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (25.0) |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| AE-related deaths | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any SAE | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Discontinuation of study drug due to AEs | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
AE, adverse event; PEG, polyethylene glycol; SAE, serious adverse event; SD1, single-dose study 1; TEAE, treatment-emergent adverse event