Table 4.
Primary system organ class b |
Vericiguat + nitroglycerin (n = 24) |
Placebo + nitroglycerin (n = 12) |
---|---|---|
Number of patients (%) with at least one TEAE | 16 (66.7) | 8 (66.7) |
Hypotension | 7 (29.2) | 2 (16.7) |
Headache | 4 (16.7) | 1 (8.3) |
Nausea | 2 (8.3) | 2 (16.7) |
Fatigue | 2 (8.3) | 1 (8.3) |
Amylase increased | 1 (4.2) | 2 (16.7) |
Lipase increased | 0 | 2 (16.7) |
MedDRA, Medical Dictionary for Regulatory Activities; TEAE, treatment‐emergent adverse event.
Six profile days = 3 trough and 3 peak days for the vericiguat + nitroglycerin group (vericiguat 2.5 mg, 5 mg, and 10 mg) and placebo + nitroglycerin group.
Preferred term MedDRA version 19.0.