Table 4.
Potentially clinically significant vital signs by age group (< 75, ≥ 75 years) – Home-based and office visit measurements
| Vital sign | Increase criteria | Placebo (n = 442) | Mirabegron 25 mg (n = 226) | Mirabegron 50 mg (n = 219) | Mirabegron total (n = 445) | ||||
|---|---|---|---|---|---|---|---|---|---|
| < 75 years (n = 318) | ≥ 75 years (n = 124) | < 75 years (n = 160) | ≥ 75 years (n = 66) | < 75 years (n = 160) | ≥ 75 years (n = 59) | < 75 years (n = 320) | ≥ 75 years (n = 125) | ||
| Home-based (excluding extreme values) | |||||||||
| SBP (mmHg) | > 10 | 6/238 (2.5) | 3/87 (3.4) | 3/126 (2.4) | 0 | 8/116 (6.9) | 1/43 (2.3) | 11/242 (4.5) | 1/92 (1.1) |
| > 15 | 0 | 2/87 (2.3) | 2/126 (1.6) | 0 | 1/116 (0.9) | 0 | 3/242 (1.2) | 0 | |
| > 20 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| DBP (mmHg) | > 5 | 17/238 (7.1) | 5/87 (5.7) | 9/126 (7.1) | 4/49 (8.2) | 5/116 (4.3) | 4/43 (9.3) | 14/242 (5.8) | 8/92 (8.7) |
| > 10 | 4/238 (1.7) | 2/87 (2.3) | 1/126 (0.8) | 2/49 (4.1) | 1/116 (0.9) | 1/43 (2.3) | 2/242 (0.8) | 3/92 (3.3) | |
| > 15 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Pulse rate (bpm) | > 5 | 17/237 (7.2) | 9/86 (10.5) | 15/125 (12.0) | 6/49 (12.2) | 9/115 (7.8) | 2/43 (4.7) | 24/240 (10.0) | 8/92 (8.7) |
| > 10 | 0 | 1/86 (1.2) | 0 | 0 | 1/115 (0.9) | 0 | 1/240 (0.4) | 0 | |
| > 15 | 0 | 0 | 0 | 0 | 1/115 (0.9) | 0 | 1/240 (0.4) | 0 | |
| Office visits | |||||||||
| SBP (mmHg) | > 10 | 31/312 (9.9) | 18/121 (14.9) | 9/158 (5.7) | 9/66 (13.6) | 20/160 (12.5) | 11/59 (18.6) | 29/318 (9.1) | 20/125 (16.0) |
| > 15 | 12/312 (3.8) | 14/121 (11.6) | 7/158 (4.4) | 7/66 (10.6) | 16/160 (10.0) | 7/59 (11.9) | 23/318 (7.2) | 14/125 (11.2) | |
| > 20 | 4/312 (1.3) | 8/121 (6.6) | 5/158 (3.2) | 5/66 (7.6) | 9/160 (5.6) | 4/59 (6.8) | 14/318 (4.4) | 9/125 (7.2) | |
| DBP (mmHg) | > 5 | 37/312 (11.9) | 18/121 (14.9) | 24/158 (15.2) | 7/66 (10.6) | 32/160 (20.0) | 11/59 (18.6) | 56/318 (4.1) | 18/125 (14.4) |
| > 10 | 11/312 (3.5) | 7/121 (5.8) | 6/158 (3.8) | 5/66 (7.6) | 7/160 (4.4) | 3/59 (5.1) | 13/318 (4.1) | 8/125 (6.4) | |
| > 15 | 3/312 (1.0) | 4/121 (3.3) | 2/158 (1.3) | 3/66 (4.5) | 1/160 (0.6) | 0 | 3/318 (0.9) | 3/125 (2.4) | |
| Pulse rate (bpm) | > 5 | 47/312 (15.1) | 20/121 (16.5) | 20/158 (12.7) | 8/66 (12.1) | 29/160 (18.1) | 9/59 (15.3) | 49/318 (15.4) | 17/125 (13.6) |
| > 10 | 13/312 (4.2) | 2/121 (1.7) | 5/158 (3.2) | 4/66 (6.1) | 10/160 (6.3) | 5/59 (8.5) | 15/318 (4.7) | 9/125 (7.2) | |
| > 15 | 6/312 (1.9) | 1/121 (0.8) | 1/158 (0.6) | 1/66 (1.5) | 5/160 (3.1) | 0 | 6/318 (1.9) | 1/125 (0.8) | |
DBP diastolic blood pressure, SBP systolic blood pressure
Data are presented as n/N (%)
N = number of patients with at least one non-missing value during treatment. Number and percentage of patients meeting each criteria on 2 consecutive post-baseline visits are summarized