Table 3.
Summary of adverse events by age subgroup and treatment (safety set)
| Safety population | Patients aged ≥ 65 years | Patients aged ≥ 75 yearsa | Overall | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Placebo (N = 228) | Vibegron (N = 246) | Tolterodine (N = 171) | Placebo (N = 60) | Vibegron (N = 75) | Tolterodine (N = 48) | Placebo (N = 540) | Vibegron (N = 545) | Tolterodine (N = 430) | |
| One or more TEAE | 85 (37.3) | 110 (44.7) | 73 (42.7) | 24 (40.0) | 37 (49.3) | 24 (50.0) | 180 (33.3) | 211 (38.7) | 166 (38.6) |
| AEs occurring in ≥ 2% of patients in the vibegron subgroups | |||||||||
| UTI | 18 (7.9) | 14 (5.7) | 11 (6.4) | 4 (6.7) | 6 (8.0) | 4 (8.3) | 33 (6.1) | 27 (5.0) | 25 (5.8) |
| Headache | 5 (2.2) | 11 (4.5) | 4 (2.3) | 2 (3.3) | 2 (2.7) | 1 (2.1) | 13 (2.4) | 22 (4.0) | 11 (2.6) |
| Dry mouth | 2 (0.9) | 8 (3.3) | 12 (7.0) | 1 (1.7) | 1 (1.3) | 2 (4.2) | 5 (0.9) | 9 (1.7) | 28 (6.5) |
| URTI | 2 (0.9) | 8 (3.3) | 1 (0.6) | 1 (1.7) | 3 (4.0) | 0 | 4 (0.7) | 11 (2.0) | 2 (0.5) |
| Nasopharyngitis | 5 (2.2) | 6 (2.4) | 6 (3.5) | 2 (3.3) | 2 (2.7) | 1 (2.1) | 9 (1.7) | 15 (2.8) | 11 (2.6) |
| Diarrhea | 2 (0.9) | 6 (2.4) | 6 (3.5) | 2 (3.3) | 3 (4.0) | 2 (4.2) | 6 (1.1) | 12 (2.2) | 9 (2.1) |
| Nausea | 3 (1.3) | 5 (2.0) | 1 (0.6) | 2 (3.3) | 2 (2.7) | 0 | 6 (1.1) | 12 (2.2) | 5 (1.2) |
| Dyspnea | 0 | 4 (1.6) | 0 | 0 | 3 (4.0) | 0 | 1 (0.2) | 4 (0.7) | 1 (0.2) |
| Back pain | 3 (1.3) | 3 (1.2) | 2 (1.2) | 2 (3.3) | 2 (2.7) | 1 (2.1) | 5 (0.9) | 3 (0.6) | 4 (0.9) |
| Urinary retention | 1 (0.4) | 3 (1.2) | 2 (1.2) | 0 | 2 (2.7) | 2 (4.2) | 2 (0.4) | 3 (0.6) | 3 (0.7) |
| Rash | 1 (0.4) | 3 (1.2) | 1 (0.6) | 1 (1.7) | 2 (2.7) | 0 | 4 (0.7) | 4 (0.7) | 1 (0.2) |
| Flatulence | 2 (0.9) | 2 (0.8) | 1 (0.6) | 0 | 2 (2.7) | 0 | 3 (0.6) | 2 (0.4) | 1 (0.2) |
| Somnolence | 1 (0.4) | 2 (0.8) | 1 (0.6) | 0 | 2 (2.7) | 1 (2.1) | 2 (0.4) | 2 (0.4) | 2 (0.5) |
| Select cardiovascular AEs | |||||||||
| Hypertensionb | 7 (3.1) | 3 (1.2) | 5 (2.9) | 2 (3.3) | 1 (1.3) | 1 (2.1) | 9 (1.7) | 9 (1.7) | 11 (2.6) |
| Blood pressure increased | 2 (0.9) | 2 (0.8) | 6 (3.5) | 1 (1.7) | 0 | 4 (8.3) | 5 (0.9) | 4 (0.7) | 8 (1.9) |
| Dizziness | 2 (0.9) | 2 (0.8) | 2 (1.2) | 1 (1.7) | 0 | 1 (2.1) | 6 (1.1) | 5 (0.9) | 4 (0.9) |
| Hypotension | 1 (0.4) | 1 (0.4) | 1 (0.6) | 0 | 1 (1.3) | 1 (2.1) | 1 (0.2) | 1 (0.2) | 1 (0.2) |
| Atrial fibrillation | 1 (0.4) | 1 (0.4) | 1 (0.6) | 0 | 1 (1.3) | 1 (2.1) | 1 (0.2) | 1 (0.2) | 1 (0.2) |
| Syncope | 2 (0.9) | 0 | 1 (0.6) | 0 | 0 | 1 (2.1) | 2 (0.4) | 0 | 1 (0.2) |
Data are presented as n (%) unless otherwise indicated
AE adverse event, TEAE treatment-emergent AE, URTI upper respiratory tract infection, UTI urinary tract infection
aA subset of the group aged ≥ 65 years
bHypertension was defined as follows: for patients without baseline hypertension, an average of three systolic blood pressure readings ≥ 140 mmHg and/or diastolic blood pressure readings ≥ 90 mmHg at two consecutive visits; for patients with baseline hypertension, an average of three readings showing increases from baseline of ≥ 20 mmHg systolic blood pressure or ≥ 10 mmHg diastolic blood pressure at two consecutive visits; for any patients, increased dosing or initiation of any medication to treat hypertension