Table 2.
Treatment-emergent adverse events by age group (< 75, ≥ 75 years)—safety analysis set
| TEAEsa | 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) | |
| One or more TEAE | 125 (39.3) | 49 (39.5) | 65 (40.6) | 35 (53.0) | 80 (50.0) | 29 (49.2) | 145 (45.3) | 64 (51.2) |
| Drug-related TEAEsb | 43 (13.5) | 14 (11.3) | 30 (18.8) | 17 (25.8) | 29 (18.1) | 8 (13.6) | 59 (18.4) | 25 (20.0) |
| Serious TEAEs | 9 (2.8) | 3 (2.4) | 5 (3.1) | 2 (3.0) | 7 (4.4) | 1 (1.7) | 12 (3.8) | 3 (2.4) |
| Serious drug-related TEAEsb | 2 (0.6) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| TEAEs leading to discontinuation | 6 (1.9) | 8 (6.5) | 6 (3.8) | 2 (3.0) | 4 (2.5) | 2 (3.4) | 10 (3.1) | 4 (3.2) |
| Drug-related TEAEs leading to discontinuationb | 5 (1.6) | 2 (1.6) | 4 (2.5) | 2 (3.0) | 2 (1.3) | 2 (3.4) | 6 (1.9) | 4 (3.2) |
| Cardiac disorders | 3 (0.9) | 2 (1.6) | 2 (1.3) | 0 | 7 (4.4) | 0 | 9 (2.8) | 0 |
| Most frequent TEAEsc | ||||||||
| Urinary tract infectiond | 21 (6.6) | 10 (8.1) | 11 (6.9) | 5 (7.6) | 5 (3.1) | 4 (6.8) | 16 (5.0) | 9 (7.2) |
| Headache | 8 (2.5) | 4 (3.2) | 12 (7.5) | 3 (4.5) | 4 (2.5) | 4 (6.8) | 16 (5.0) | 7 (5.6) |
| Diarrhea | 2 (0.6) | 4 (3.2) | 8 (5.0) | 3 (4.5) | 2 (1.3) | 0 | 10 (3.1) | 3 (2.4) |
| Fatigue | 8 (2.5) | 6 (4.8) | 3 (1.9) | 3 (4.5) | 3 (1.9) | 1 (1.7) | 6 (1.9) | 4 (3.2) |
| Upper respiratory tract infection | 6 (1.9) | 4 (3.2) | 3 (1.9) | 0 | 5 (3.1) | 2 (3.4) | 8 (2.5) | 2 (1.6) |
| Nausea | 5 (1.6) | 1 (0.8) | 4 (2.5) | 3 (4.5) | 1 (0.6) | 0 | 5 (1.6) | 3 (2.4) |
| Dizziness | 7 (2.2) | 0 | 1 (0.6) | 0 | 5 (3.1) | 0 | 6 (1.9) | 0 |
| Nasopharyngitis | 7 (2.2) | 3 (2.4) | 2 (1.3) | 1 (1.5) | 2 (1.3) | 0 | 4 (1.3) | 1 (0.8) |
Data are presented as N (%) unless otherwise indicated. MedDRA version 20.1. Safety analysis set: all randomized subjects who received one or more dose of study medication
TEAE treatment-emergent adverse event
aTEAEs are defined as adverse events that started or worsened in the period from first double-blind medication intake until 30 days after the last double-blind medication intake. The number of patients reporting an event are presented
bPossible or probable, as assessed by the investigator, or where relationship was missing
cPreferred term; affecting ≥ 2% of any treatment group
dEscherichia urinary tract infection, streptococcal urinary tract infection, urinary tract infection, or urinary tract infection bacterial