Table 2.
Overview of treatment-emergent adverse events (SAF)
| Number of subjects (%) | Study 178-CL-044 (SAF) | Study 178-CL-074 (SAF) | Pooled Phase III studies (SAF) | ||||
|---|---|---|---|---|---|---|---|
| Placebo | Mirabegron | Placebo (n = 433) | Mirabegron 25 mg (n = 432) | Placebo (n = 1,380) | Mirabegron 50 mg (n = 1,375) | ||
| (n = 169) | 25 mg (n = 169) | 50 mg (n = 169) | |||||
| Any TEAE | 73 (43.2) | 74 (43.8) | 74 (43.8) | 217 (50.1) | 210 (48.6) | 658 (47.7) | 647 (47.1) |
| Drug-related TEAE | 26 (15.4) | 34 (20.1) | 38 (22.5) | 77 (17.8) | 87 (20.1) | 232 (16.8) | 256 (18.6) |
| TEAE leading to discontinuation | 5 (3.0) | 10 (5.9) | 3 (1.8) | 16 (3.7) | 17 (3.9) | 46 (3.3) | 53 (3.9) |
| Drug-related TEAE leading to discontinuation | 3 (1.8) | 8 (4.7) | 2 (1.2) | 8 (1.8) | 11 (2.5) | 27 (2.0) | 35 (2.5) |
| SAE | 1 (0.6) | 1 (0.6) | 1 (0.6) | 12 (2.8) | 7 (1.6) | 29 (2.1) | 29 (2.1) |
| Drug-related SAE | NA | NA | NA | 2 (0.5) | 3 (0.7) | 6 (0.4) | 7 (0.5) |
| Common TEAEs by preferred term (reported by ≥3 % in any group) | |||||||
| Hypertension | 0 | 3 (1.8) | 3 (1.8) | 37 (8.5) | 49 (11.3) | 105 (7.6) | 103 (7.5) |
| Nasopharyngitis | 12 (7.1) | 3 (1.8) | 4 (2.4) | 14 (3.2) | 15 (3.5) | 35 (2.5) | 54 (3.9) |
| Urinary tract infection | 5 (3.0) | 11 (6.5) | 3 (1.8) | 10 (2.3) | 18 (4.2) | 25 (1.8) | 40 (2.9) |
| Headache | 8 (4.7) | 6 (3.6) | 8 (4.7) | 19 (4.4) | 9 (2.1) | 42 (3.0) | 44 (3.2) |
| Dry mouth | 3 (1.8) | 5 (3.0) | 3 (1.8) | 9 (2.1) | 8 (1.9) | 29 (2.1) | 23 (1.7) |
| Constipation | 2 (1.2) | 2 (1.2) | 6 (3.6) | 5 (1.2) | 7 (1.6) | 20 (1.4) | 22 (1.6) |
| Influenza | 4 (2.4) | 5 (3.0) | 7 (4.1) | 7 (1.6) | 3 (0.7) | 19 (1.4) | 19 (1.4) |
| Dizziness | 1 (0.6) | 1 (0.6) | 6 (3.6) | 2 (0.5) | 10 (2.3) | 12 (0.9) | 13 (0.9) |
| Asthenia | 0 | 1 (0.6) | 6 (3.6) | 0 | 0 | 2 (0.1) | 1 (0.1) |
| Drug-related* TEAEs by preferred term (reported by ≥3 % in any group) | |||||||
| Hypertension | 0 | 3 (1.8) | 2 (1.2) | 23 (5.3) | 30 (6.9) | 63 (4.6) | 65 (4.7) |
| Headache | 4 (2.4) | 6 (3.6) | 5 (3.0) | 9 (2.1) | 4 (0.9) | 18 (1.3) | 28 (2.0) |
| Dry mouth | 3 (1.8) | 5 (3.0) | 3 (1.8) | 8 (1.8) | 7 (1.6) | 22 (1.6) | 13 (0.9) |
| Dizziness | 1 (0.6) | 0 | 6 (3.6) | 1 (0.2) | 7 (1.6) | 8 (0.6) | 10 (0.7) |
SAF safety analysis set, TEAE treatment-emergent adverse event, SAE serious adverse event, NA not available
* Possible or probable, as assessed by the investigator, or records where relationship was missing