Table 7.
Summary of subjects with TEAEs in the SV interaction study (safety analysis set, n = 32)
| Number of subjects with specified TEAE | Vericiguat 2.5 mg SD (n = 16) | Placebo SD (n = 16) | SV 49/51 mg bid (n = 31) | SV 97/103 mg bid (n = 31) | SV 97/103 mg bid + vericiguat 2.5 mg qd (n = 15) | SV 97/103 mg bid + placebo (n = 15) |
|---|---|---|---|---|---|---|
| Any AE | 2 (12.5) | 3 (18.8) | 6 (19.4) | 12 (38.7) | 7 (46.7) | 7 (46.7) |
| Vericiguat-related | 0 (0.0) | 1 (6.3) | 0 (0.0) | 0 (0.0) | 2 (13.3) | 4 (26.7) |
| SV-related | 0 (0.0) | 0 (0.0) | 5 (16.1) | 9 (29.0) | 3 (20.0) | 4 (26.7) |
| Procedure-related | 0 (0.0) | 1 (6.3) | 0 (0.0) | 1 (3.2) | 0 (0.0) | 0 (0.0) |
| AE-related deaths | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Any SAE | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Discontinuation of vericiguat due to an AE | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (3.2) | 0 (0.0) | 0 (0.0) |
| Discontinuation of SV due to an AE | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (3.2) | 0 (0.0) | 0 (0.0) |
Data are expressed as n (%)
AE adverse event, bid twice daily, qd once daily, SAE serious adverse event, SD single dose, SV sacubitril/valsartan, TEAE treatment-emergent adverse event