Table 3.
Summary of AEs and laboratory changes from baseline in patients with baseline NT‐proBNP levels in Quartiles 1–3 (Q1–Q3) and Quartile 4 (Q4)—all safety patients
| Patients with baseline NT‐proBNP in Q1–A3 | Patients with baseline NT‐proBNP in Q4 | P value a | P value b | |||||
|---|---|---|---|---|---|---|---|---|
| Characteristics | Vericiguat n = 1798 | Placebo n = 1803 | Total n = 3601 | Vericiguat n = 616 | Placebo n = 584 | Total n = 1200 | ||
| AEs, n (%) | n = 1798 | n = 1803 | n = 3601 | n = 616 | n = 584 | n = 1200 | ||
| AEs | 1449 (80.6) | 1459 (80.9) | 2908 (80.8) | 491 (79.7) | 474 (81.2) | 965 (80.4) | NS | NS |
| Death c | 41 (2.3) | 44 (2.4) | 85 (2.4) | 38 (6.2) | 32 (5.5) | 70 (5.8) | <0.0001 | NS |
| SAEs | 582 (32.4) | 580 (32.2) | 1162 (32.3) | 211 (34.3) | 248 (42.5) | 459 (38.3) | 0.0001 | 0.0101 |
| Drug‐related AEs | 271 (15.1) | 205 (11.4) | 476 (13.2) | 74 (12.0) | 69 (11.8) | 143 (11.9) | NS | NS |
| Drug‐related SAEs | 20 (1.1) | 14 (0.8) | 34 (0.9) | 8 (1.3) | 4 (0.7) | 12 (1.0) | NS | NS |
| AEs that led to treatment discontinuation | 111 (6.2) | 97 (5.4) | 208 (5.8) | 49 (8.0) | 51 (8.7) | 100 (8.3) | 0.0017 | NS |
| SAEs that led to treatment discontinuation | 52 (2.9) | 48 (2.7) | 100 (2.8) | 18 (2.9) | 34 (5.8) | 52 (4.3) | 0.0217 | 0.0254 |
| Events of clinical interest, n (%) | n = 1798 | n = 1803 | n = 3601 | n = 616 | n = 584 | n = 1201 | ||
| Symptomatic hypotension | 174 (9.7) | 131 (7.3) | 305 (8.5) | 44 (7.1) | 53 (9.1) | 97 (8.1) | NS | |
| Syncope | 77 (4.3) | 62 (3.4) | 139 (3.9) | 21 (3.4) | 21 (3.6) | 42 (3.5) | NS | |
| Hepatic events | 14 (0.8) | 11 (0.6) | 25 (0.7) | 9 (1.5) | 2 (0.3) | 11 (0.9) | NS | |
| Changes in laboratory values, n/N (%) | ||||||||
| eGFR decrease ≥25% | 407/1583 (25.7) | 395/1621 (24.4) | 802/3204 (25.0) | 147/460 (32.0) | 121/448 (27.0) | 268/908 (29.5) | 0.008 | NS |
| eGFR decrease ≥50% | 42/1583 (2.7) | 43/1621 (2.7) | 85/3204 (2.7) | 28/460 (6.1) | 16/448 (3.6) | 44/908 (4.8) | 0.0025 | NS |
| Haematocrit decrease by 10 percentage points and value <LLN | 54/1538 (3.5) | 32/1566 (2.0) | 86/3104 (2.8) | 25/447 (5.6) | 10/431 (2.3) | 35/878 (4.0) | NS | NS |
| Haemoglobin decrease ≥3.0 g/dL and value <LLN | 70/1538 (4.6) | 48/1566 (3.1) | 118/3104 (3.8) | 30/447 (6.7) | 11/431 (2.6) | 41/878 (4.7) | NS | NS |
AE, adverse event; eGFR, estimated glomerular filtration rate; ITT, intent‐to‐treat; LLN, lower limit of normal; NS, not statistically significant; NT‐proBNP, N‐terminal pro‐brain natriuretic peptide; SAE, serious adverse event.
Includes events/measurements from the day of first dose of study drug to 14 days after the last dose of study drug.
a
Based on chi‐square test for comparing the total between Q1–Q3 and Q4.
b
Based on the Chi‐square test for comparing among vericiguat/placebo and NT‐proBNP subgroups.
c
Adverse event associated with a fatal outcome.