Table 2.
Treatment-emergent adverse events
| System organ classa Preferred termb |
Number of patients with TEAE, n (%) | |
|---|---|---|
| Mirabegron initiators (N = 613)c | Antimuscarinic initiators (N = 901)d | |
| Any TEAE | 203 (33.1) | 152 (16.9) |
| Gastrointestinal disorders | 116 (18.9) | 77 (8.5) |
| Dry mouth | 78 (12.7) | 57 (6.3) |
| Constipation | 48 (7.8) | 39 (4.3) |
| Nausea | 19 (3.1) | 11 (1.2) |
| Nervous system disorders | 74 (12.1) | 35 (3.9) |
| Headache | 54 (8.8) | 19 (2.1) |
| Somnolence | 30 (4.9) | 17 (1.9) |
| Dizziness | 5 (0.8) | 2 (0.2) |
| Any serious TEAE | 25 (4.1) | 16 (1.8) |
| Respiratory, thoracic, and mediastinal disorders | 7 (1.1) | 3 (0.3) |
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | 4 (0.7) | 6 (0.7) |
TEAE treatment-emergent adverse event
aSystem organ class TEAEs reported in > 5% and serious TEAEs reported in > 0.5% of total population
bMost frequent preferred term TEAEs
cAll TEAEs for mirabegron initiators (regardless of relationship to study treatment) were monitored and reported to the study sponsor throughout the study (mandatory reporting)
dIdentification of TEAEs for antimuscarinic initiators was at the discretion of the investigator (discretionary reporting). The only exception was for solifenacin where mandatory reporting of TEAEs was required