Table III.
Summary of Most Frequently Reported Treatment‐Emergent AEs
| AE | Nebivolol Dose | Total (Nebivolol (n=828) | ||||||
|---|---|---|---|---|---|---|---|---|
| Placebo (n=81) | 1.25 mg (n=83) | 2.5 mg (n=82) | 5 mg (n=165) | 10 mg (n=166) | 20 mg (n=166) | 40 mg (n=166) | ||
| Any event | 33 (40.7) | 29 (34.9) | 36 (43.9) | 73 (44.2) | 76 (45.8) | 84 (50.6) | 84 (50.6) | 382 (46.1) |
| Headache | 6 (7.4) | 6 (7.2) | 5 (6.1) | 12 (7.3) | 10 (6.0) | 11 (6.6) | 15 (9.0) | 59 (7.1) |
| Fatigue | 2 (2.5) | 1 (1.2) | 5 (6.1) | 4 (2.4) | 3 (1.8) | 9 (5.4) | 8 (4.8) | 30 (3.6) |
| Nasopharyngitis | 6 (7.4) | 2 (2.4) | 4 (4.9) | 5 (3.0) | 3 (1.8) | 5 (3.0) | 5 (3.0) | 24 (2.9) |
| Diarrhea NOS | 2 (2.5) | 1 (1.2) | 2 (2.4) | 4 (2.4) | 5 (3.0) | 6 (3.6) | 5 (3.0) | 23 (2.8) |
| Dizziness | 3 (3.7) | 1 (1.2) | 4 (4.9) | 2 (1.2) | 2 (1.2) | 5 (3.0) | 9 (5.4) | 23 (2.8) |
| Increased CRP level | 1 (1.2) | 1 (1.2) | 5 (6.1) | 3 (1.8) | 4 (2.4) | 5 (3.0) | 4 (2.4) | 22 (2.7) |
| Nausea | 1 (1.2) | 0 | 2 (2.4) | 2 (1.2) | 5 (3.0) | 4 (2.4) | 2 (1.2) | 15 (1.8) |
| Sinusitis NOS | 0 | 1 (1.2) | 0 | 2 (1.2) | 3 (1.8) | 4 (2.4) | 3 (1.8) | 13 (1.6) |
| URT infection NOS | 2 (2.5) | 0 | 1 (1.2) | 2 (1.2) | 1 (0.6) | 4 (2.4) | 5 (3.0) | 13 (1.6) |
| Peripheral edema | 0 | 2 (2.4) | 1 (1.2) | 2 (1.2) | 3 (1.8) | 1 (0.6) | 1 (0.6) | 10 (1.2) |
| Dyspepsia | 2 (2.5) | 0 | 1 (1.2) | 2 (1.2) | 1 (0.6) | 3 (1.8) | 1 (0.6) | 8 (1.0) |
| Bronchitis NOS | 0 | 2 (2.4) | 0 | 1 (0.6) | 1 (0.6) | 2 (1.2) | 1 (0.6) | 7 (0.8) |
| Cough | 1 (1.2) | 3 (3.6) | 2 (2.4) | 1 (0.6) | 1 (0.6) | 0 | 0 | 7 (0.8) |
| Abbreviations: AE, adverse event; CRP, C‐reactive protein; NOS, not otherwise specified; URT, upper respiratory tract. | ||||||||