Table 3.
Overall incidence of TEAEs, most common TEAEs (⩾2% in any treatment group), and TEAEs of special interest in male patients from the pooled phase III studies, 12-month study, and phase IIIb study (SAF).
| Pooled studies (12 weeks) (SCORPIO/ARIES/CAPRICORN) |
TAURUS (52 weeks) |
BEYOND (12 weeks) |
||||
|---|---|---|---|---|---|---|
| TEAE (preferred term), n (%) | Placebo (n = 378) | Mirabegron 50 mg (n = 393) | Mirabegron 50 mg (n = 210) | Tolterodine ER 4 mg (n = 212) | Mirabegron 50 mg (n = 224) | Solifenacin 5 mg (n = 225) |
| Overall TEAE in males | 171/378 (45.2) | 181/393 (46.1) | 126/210 (60.0) | 132/212 (62.3) | 55/224 (24.5) | 59/225 (26.2) |
| Overall TEAE in total population | 658/1380 (47.7) | 647/1375 (47.1) | 485/812 (59.7) | 508/812 (62.6) | 274/936 (29.3) | 282/934 (30.2) |
| Common TEAEs (⩾2% in any group) | ||||||
| Hypertension | 35 (9.3) | 43 (10.9) | 26 (12.4) | 25 (11.8) | – | – |
| Nasopharyngitis | 8 (2.1) | 23 (5.9) | 7 (3.3) | 7 (3.3) | 5 (2.2) | 3 (1.3) |
| Headache | 5 (1.3) | 10 (2.5) | 5 (2.4) | 7 (3.3) | 7 (3.1) | 3 (1.3) |
| Cough | – | – | 5 (2.4) | 1 (0.5) | – | – |
| Constipation | 6 (1.6) | 8 (2.0) | 6 (2.9) | 4 (1.9) | 4 (1.8) | 6 (2.7) |
| Diarrhea | – | – | 2 (1.0) | 5 (2.4) | – | – |
| Dry mouth | 9 (2.4) | 6 (1.5) | 7 (3.3) | 17 (8.0) | 8 (3.5) | 15 (6.7) |
| Urinary tract infection | – | – | 4 (1.9) | 5 (2.4) | – | – |
| Dizziness | – | – | 5 (2.4) | 7 (3.3) | – | – |
| Back pain | 8 (2.1) | 4 (1.0) | 9 (4.3) | 2 (0.9) | – | – |
| Tachycardia | – | – | 2 (1.0) | 8 (3.8) | – | – |
| Nausea | – | – | 1 (0.5) | 6 (2.8) | – | – |
| Fatigue | – | – | 2 (1.0) | 5 (2.4) | – | – |
| Influenza | – | – | 3 (1.4) | 6 (2.8) | – | – |
| Pain in extremity | – | – | 5 (2.4) | 1 (0.5) | – | – |
| Cystitis | – | – | 3 (1.4) | 5 (2.4) | – | – |
| TEAEs of special interest | ||||||
| Urinary retention | 1 (0.3) | 1 (0.3) | 0 | 3 (1.4) | 1 (0.1) | 0 |
| Acute urinary retention | 1 (0.3) | 1 (0.3) | 0 | 1 (0.5) | 0 | 0 |
| Blurred vision | 0 | 1 (0.3) | 3 (1.4) | 1 (0.5) | 2 (0.2) | 0 |
| Dyspepsia | 4 (1.1) | 2 (0.5) | 1 (0.5) | 4 (1.9) | 1 (0.1) | 1 (0.1) |
| Hypertension | 35 (9.3) | 43 (10.9) | 26 (12.4) | 25 (11.8) | 4 (0.4) | 4 (0.4) |
ER, extended release; SAF, safety analysis set; TEAE, treatment-emergent adverse events